Trial Outcomes & Findings for Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children (NCT NCT01669642)

Last Updated: 2019-04-25

Results Overview

ED50 is the dose of rapidly administered ketamine that achieves effective sedation in 50% of patients. ED95 is the dose of ketamine that can provide effective sedation in 95% of children undergoing abscess drainage or fracture reduction. ED95 will be calculated for the 3 age groups (2-5, 6-11 and 12-17) independently for both the procedures: abscess drainage and fracture reduction.

Recruitment status

COMPLETED

Study phase

Target enrollment

111 participants

Primary outcome timeframe

Dose administration through 5 minutes

Results posted on

2019-04-25

Participant Flow

children between 2-18 years of age who presented to st louis children's hospital emergency department between april 2012 and august 2014 with a fracture that needed reduction or a skin abscess that needed drainage under sedation were approached for enrollment.

Participant milestones

Participant milestones
Measure	Fracture Reduction Group 2-5 Years children between 2-5 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group.	Fracture Reduction Group 6-11 Years children between 6-11 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group.	Fracture Reduction Group 12-17 Years children between 12-17 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group.	Abscess Drainage Group 2-5 Years children between 2-5 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group.	Abscess Drainage Group 6-11 Years children between 6-11 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group.	Abscess Drainage Group 12-17 Years children between 12-17 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group.
Overall Study STARTED	20	20	20	21	20	10
Overall Study COMPLETED	20	20	20	20	20	0
Overall Study NOT COMPLETED	0	0	0	1	0	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fracture Reduction Group 2-5 Years n=20 Participants participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.	Fracture Reduction Group 6-11 Years n=20 Participants participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.	Fracture Reduction Group 12-17 Years n=20 Participants participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.	Abscess Drainage Group 2-5 Years n=20 Participants participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.	Abscess Drainage Group 6-11 Years n=20 Participants participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.	Total n=100 Participants Total of all reporting groups
Age, Continuous	4.8 years n=5 Participants	9.2 years n=7 Participants	13.7 years n=5 Participants	2.9 years n=4 Participants	7.2 years n=21 Participants	7.2 years n=10 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants	11 Participants n=21 Participants	35 Participants n=10 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants	12 Participants n=4 Participants	9 Participants n=21 Participants	65 Participants n=10 Participants
Race/Ethnicity, Customized african american	5 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	8 Participants n=21 Participants	32 Participants n=10 Participants
Race/Ethnicity, Customized Caucasian	13 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	12 Participants n=21 Participants	38 Participants n=10 Participants
Race/Ethnicity, Customized other	2 Participants n=5 Participants	17 Participants n=7 Participants	10 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	30 Participants n=10 Participants
Patients who received Opioids prior to sedation	19 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	56 Participants n=10 Participants
time between opioid administration and sedation start time	116 minutes n=5 Participants	96 minutes n=7 Participants	129 minutes n=5 Participants	0 minutes n=4 Participants	0 minutes n=21 Participants	116 minutes n=10 Participants
fracture characteristics Non displaced fracture	10 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	21 Participants n=10 Participants
fracture characteristics displaced fracture but not overriding	6 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	24 Participants n=10 Participants
fracture characteristics displaced fracture and overriding	4 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	15 Participants n=10 Participants
fracture characteristics no fracture	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	20 Participants n=4 Participants	20 Participants n=21 Participants	40 Participants n=10 Participants

PRIMARY outcome

Timeframe: Dose administration through 5 minutes

Population: 100 children were enrolled in 5 different groups depending on the age and type of procedure.

Outcome measures

Outcome measures
Measure	Fracture Reduction Group 2-5 Years n=20 Participants children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Fracture Reduction Group 6-11 Years n=20 Participants children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Fracture Reduction Group 12-17 Years n=20 Participants children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Abscess Drainage Group 2-5 Years n=20 Participants children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.	Abscess Drainage Group 6-11 Years n=20 Participants children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
Median Effective Dose (ED50) and ED95 of Rapidly Administered Ketamine	0.7 mg/kg of ketamine dose Interval 0.6 to 0.9	0.5 mg/kg of ketamine dose Interval 0.5 to 0.7	0.6 mg/kg of ketamine dose Interval 0.5 to 0.8	0.9 mg/kg of ketamine dose Interval 0.7 to 1.1	0.6 mg/kg of ketamine dose Interval 0.4 to 0.9

PRIMARY outcome

Timeframe: Dose administration through 5 minutes

ED95 is the dose of ketamine effective for 95% of children. this outcome is estimated from ED50.

Outcome measures

Outcome measures
Measure	Fracture Reduction Group 2-5 Years n=20 Participants children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Fracture Reduction Group 6-11 Years n=20 Participants children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Fracture Reduction Group 12-17 Years n=20 Participants children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Abscess Drainage Group 2-5 Years n=20 Participants children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.	Abscess Drainage Group 6-11 Years n=20 Participants children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
ED95	0.7 mg/kg of ketamine dose	0.7 mg/kg of ketamine dose	0.8 mg/kg of ketamine dose	1.1 mg/kg of ketamine dose	1.1 mg/kg of ketamine dose

SECONDARY outcome

Timeframe: Administration of ketamine through 2 week follow up call

patients who experienced vomiting while in the ED or after discharge

Outcome measures

Outcome measures
Measure	Fracture Reduction Group 2-5 Years n=20 Participants children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Fracture Reduction Group 6-11 Years n=20 Participants children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Fracture Reduction Group 12-17 Years n=20 Participants children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Abscess Drainage Group 2-5 Years n=20 Participants children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.	Abscess Drainage Group 6-11 Years n=20 Participants children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
Vomiting No vomiting	13 Participants	16 Participants	16 Participants	17 Participants	19 Participants
Vomiting vomiting in the ED	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Vomiting Vomiting after discharge	6 Participants	3 Participants	3 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Dose administration through 1 minute

This is a measure of sedation effectiveness; to assess the effectiveness of first dose of ketamine administered. Possible values for the scale range from 0 to 6. A sedation score of 2 or less is considered adequate sedation. Values more than 2 indicate state of inadequate sedation. higher values indicate the need for additional doses of sedation. Patients who achieved a score of 2 or less are considered effective sedation and a score of \>2 are considered ineffective sedations.

Outcome measures

Outcome measures
Measure	Fracture Reduction Group 2-5 Years n=20 Participants children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Fracture Reduction Group 6-11 Years n=20 Participants children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Fracture Reduction Group 12-17 Years n=20 Participants children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.	Abscess Drainage Group 2-5 Years n=20 Participants children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.	Abscess Drainage Group 6-11 Years n=20 Participants children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
Number of Participants With Wisconsin Sedation Scale Score of 2 or Less at 1 Minute After First Dose of Ketamine	12 participants	9 participants	10 participants	13 participants	10 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Time of administration of ketamine through sedation recovery

during recovery, all participants are monitored for recovery to baseline at which point participants are ready for discharge. we will document the time from induction to recovery to aldrete score of 10.