Trial Outcomes & Findings for Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures (NCT NCT03781817)
NCT ID: NCT03781817
Last Updated: 2023-04-20
Results Overview
Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Induction up to 10 minutes
Results posted on
2023-04-20
Participant Flow
Patient screening, enrollment and informed consent will be obtained in the emergency department (ED) of Children's of Alabama (COA). Data collection will take place in the ED as well as in Children's Park Place, Suite 110. The remainder of the research, including data analysis, and collaboration amongst the principal investigator and the sub-investigators, will be conducted in Children's Park Place, Suite 110.
Participant milestones
| Measure |
Intravenous Ketamine
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
Intranasal Ketamine
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
23
|
|
Overall Study
COMPLETED
|
17
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Baseline characteristics by cohort
| Measure |
Intravenous Ketamine
n=17 Participants
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
Intranasal Ketamine
n=23 Participants
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5 years
STANDARD_DEVIATION 1.65 • n=5 Participants
|
5 years
STANDARD_DEVIATION 1.99 • n=7 Participants
|
5 years
STANDARD_DEVIATION 1.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Allergies
Yes
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Allergies
No
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Weight (kg)
|
18.1 weight in kilograms
STANDARD_DEVIATION 3.2 • n=5 Participants
|
18.4 weight in kilograms
STANDARD_DEVIATION 4.13 • n=7 Participants
|
18.15 weight in kilograms
STANDARD_DEVIATION 3.72 • n=5 Participants
|
|
Past Medical History
Yes
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Past Medical History
No
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Past Surgical History
Yes
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Past Surgical History
No
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Induction up to 10 minutesDetermine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation.
Outcome measures
| Measure |
Intravenous Ketamine
n=17 Participants
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
Intranasal Ketamine
n=23 Participants
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
|---|---|---|
|
Number of Participants Who Achieved Adequate Sedation.
|
17 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From induction to discharge from sedation by emergency physician, up to 3 hours.Population: Number of participants that required rescue dosing either due to inadequate sedation at 10 minutes or after adequate sedation at 10 minutes but requiring more sedation to complete the procedure.
Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications.
Outcome measures
| Measure |
Intravenous Ketamine
n=17 Participants
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
Intranasal Ketamine
n=23 Participants
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
|---|---|---|
|
Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.
|
7 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: From induction to discharge from the emergency department.Population: Percentage of participants that experienced any possible adverse events from sedation with either intravenous or intranasal ketamine.
Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.
Outcome measures
| Measure |
Intravenous Ketamine
n=17 Participants
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
Intranasal Ketamine
n=23 Participants
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
|---|---|---|
|
Percentage of Participants With Non-serious Adverse Events.
Yes
|
1 Participants
|
3 Participants
|
|
Percentage of Participants With Non-serious Adverse Events.
No
|
16 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From induction to discharge from sedation by the emergency physician.Population: Describes the duration of sedation (in minutes) from the start of induction to when participant was discharged from sedation by the emergency physician.
Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 2 or less is set to be satisfactory for discharge from sedation.
Outcome measures
| Measure |
Intravenous Ketamine
n=17 Participants
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
Intranasal Ketamine
n=23 Participants
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
|---|---|---|
|
Duration of Sedation Using Modified Ramsay Sedation Scale.
|
65.71 Minutes
Standard Deviation 32.54
|
101.21 Minutes
Standard Deviation 52.4
|
SECONDARY outcome
Timeframe: From arrival to emergency department to discharge order entered by emergency physician.Population: Duration of total emergency department stay from arrival to the emergency department to discharge order entered by emergency physician.
Measured from time of arrival to emergency department to discharge order.
Outcome measures
| Measure |
Intravenous Ketamine
n=17 Participants
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
Intranasal Ketamine
n=23 Participants
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
|---|---|---|
|
Duration of Emergency Department Stay.
|
325.65 Time (in minutes)
Standard Deviation 104.7
|
312.4 Time (in minutes)
Standard Deviation 67.7
|
Adverse Events
Intravenous Ketamine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Intranasal Ketamine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intravenous Ketamine
n=17 participants at risk
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
Intranasal Ketamine
n=23 participants at risk
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • From the time the induction medication (either intranasal ketamine or intranasal hypertonic saline) to discharge order by the emergency physician, up to 6 hours.
|
13.0%
3/23 • Number of events 3 • From the time the induction medication (either intranasal ketamine or intranasal hypertonic saline) to discharge order by the emergency physician, up to 6 hours.
|
Additional Information
James Statler, MD
University of Alabama at Birmingham, Department of Pediatrics
Phone: (205) 638-6048
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place