Trial Outcomes & Findings for Continuous Intraosseous Vascular Access Over 48 Hours (NCT NCT01866475)

NCT ID: NCT01866475

Last Updated: 2024-04-09

Results Overview

Presence of serious complications from 48 hour intraosseous (IO) vascular access using EZ-IO.

Recruitment status

COMPLETED

Study phase

Target enrollment

127 participants

Primary outcome timeframe

48 hours

Results posted on

2024-04-09

Participant Flow

November 2014 - January 2016: subjects with controlled diabetes and/or mild renal disease only were enrolled. January 2016 - July 2016: healthy subjects and subjects with controlled diabetes and/or mild renal disease were enrolled. Amendment for healthy subjects approved by FDA in advance of implementation.

Participant milestones

Participant milestones
Measure	Diabetes Those with controlled diabetes and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Renal Disease and Diabetes Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Healthy Adults Those who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours
Overall Study STARTED	40	3	84
Overall Study COMPLETED	39	3	79
Overall Study NOT COMPLETED	1	0	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Intraosseous Vascular Access Over 48 Hours

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Renal Disease Those with mild to moderate renal disease and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Diabetes n=40 Participants Those with controlled diabetes and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Renal Disease and Diabetes n=3 Participants Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Healthy Adults n=84 Participants Those who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Total n=127 Participants Total of all reporting groups
Age, Continuous	—	53.6 years STANDARD_DEVIATION 11.7 • n=7 Participants	47 years STANDARD_DEVIATION 12.3 • n=5 Participants	41.4 years STANDARD_DEVIATION 12.7 • n=4 Participants	45.4 years STANDARD_DEVIATION 13.5 • n=21 Participants
Sex: Female, Male Female	—	14 Participants n=7 Participants	1 Participants n=5 Participants	31 Participants n=4 Participants	46 Participants n=21 Participants
Sex: Female, Male Male	—	26 Participants n=7 Participants	2 Participants n=5 Participants	53 Participants n=4 Participants	81 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	—	10 Participants n=7 Participants	0 Participants n=5 Participants	17 Participants n=4 Participants	27 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	—	12 Participants n=7 Participants	1 Participants n=5 Participants	41 Participants n=4 Participants	54 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian / Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaii / Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic / Latino	—	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · White and Hispanic / Latino	—	17 Participants n=7 Participants	2 Participants n=5 Participants	22 Participants n=4 Participants	41 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black and Hispanic / Latino	—	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	—	40 participants n=7 Participants	3 participants n=5 Participants	84 participants n=4 Participants	127 participants n=21 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: Evaluable subjects included in primary endpoint analysis. Non-evaluable subjects, defined by protocol as subjects who withdrew consent or were discontinued from the study for non-compliance or unwillingness to comply with study requirements before completing Day 3 procedures (48 hour dwell time), were replaced. There were 6 non-evaluable subjects.

Presence of serious complications from 48 hour intraosseous (IO) vascular access using EZ-IO.

Outcome measures

Outcome measures
Measure	Renal Disease Those with mild to moderate renal disease and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Diabetes n=39 Participants Those with controlled diabetes and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Renal Disease and Diabetes n=3 Participants Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Healthy Adults n=79 Participants Those who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours
Serious Complications From Intraosseous (IO) Access	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Renal Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diabetes

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Renal Disease and Diabetes

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Healthy Adults

Serious events: 0 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Tatiana Puga

Teleflex

Phone: 2104451794

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Renal Disease Those with mild to moderate renal disease and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Diabetes n=40 participants at risk Those with controlled diabetes and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Renal Disease and Diabetes n=3 participants at risk Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours	Healthy Adults n=84 participants at risk Those who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours EZ-IO: To have an EZ-IO placed up to 48 hours
Blood and lymphatic system disorders Elevated White Blood Cells	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
General disorders Fever	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	3.6% 3/84 • Number of events 3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Skin and subcutaneous tissue disorders Imprint EZ-IO	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Surgical and medical procedures pain	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	65.0% 26/40 • Number of events 50 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	66.7% 2/3 • Number of events 4 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	89.3% 75/84 • Number of events 76 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Musculoskeletal and connective tissue disorders pain - referred pain, distal tibia	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Skin and subcutaneous tissue disorders Scar	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Musculoskeletal and connective tissue disorders soreness - arm left	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Musculoskeletal and connective tissue disorders swelling - IO site	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.5% 1/40 • Number of events 2 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	33.3% 1/3 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	6.0% 5/84 • Number of events 5 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
General disorders Vasovagal response	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	5.0% 2/40 • Number of events 2 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.4% 2/84 • Number of events 2 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Musculoskeletal and connective tissue disorders pain- left heel foot	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Musculoskeletal and connective tissue disorders soreness- left knee	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
General disorders pain - various focus points	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	17.5% 7/40 • Number of events 7 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	10.7% 9/84 • Number of events 9 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Skin and subcutaneous tissue disorders Skin - local allergy	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.4% 2/84 • Number of events 2 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Skin and subcutaneous tissue disorders burn	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.5% 1/40 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/84 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Eye disorders Conjunctivitis	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.4% 2/84 • Number of events 2 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Gastrointestinal disorders constipation	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.5% 1/40 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/84 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Gastrointestinal disorders diarrhea	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Gastrointestinal disorders emesis / nausea	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	7.5% 3/40 • Number of events 4 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/84 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Skin and subcutaneous tissue disorders erythema - knee	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.4% 2/84 • Number of events 2 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Musculoskeletal and connective tissue disorders Fractured tooth	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.5% 1/40 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/84 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
General disorders headache	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	17.5% 7/40 • Number of events 10 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	66.7% 2/3 • Number of events 2 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	11.9% 10/84 • Number of events 11 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Musculoskeletal and connective tissue disorders hoarseness	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Cardiac disorders junctional heart rate	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
General disorders light headedness	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.5% 1/40 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Musculoskeletal and connective tissue disorders muscle spasm	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.5% 1/40 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/84 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Gastrointestinal disorders nausea / upset stomach	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	7.5% 3/40 • Number of events 3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	4.8% 4/84 • Number of events 4 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Skin and subcutaneous tissue disorders rash	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Cardiac disorders sinus bradycardia	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Infections and infestations sinus infection	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	2.5% 1/40 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/84 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Infections and infestations upper respiratory infection	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	1.2% 1/84 • Number of events 1 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.
Musculoskeletal and connective tissue disorders swelling - knee posterior	— 0/0 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/40 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	0.00% 0/3 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.	3.6% 3/84 • Number of events 4 • 48 hours Subjects were routinely assessed for adverse events following intraosseous (IO) insertion catheter every 15 minutes for the first 2 hours, then every 2 hours for the remaining 48 hour dwell time. A laboratory test was done at the time of IO catheter removal to assess for osteomyelitis. No subjects were enrolled into the Renal Disease arm of the study, therefore the number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events for this group is zero.