Trial Outcomes & Findings for Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department (NCT NCT01387139)

NCT ID: NCT01387139

Last Updated: 2017-12-08

Results Overview

We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 183 participants
• Primary outcome timeframe: From enrollment through completion of follow-up, up to 7 days
• Results posted on: 2017-12-08

Participant Flow

Participant milestones

Measure	Ketamine Alone Ketamine: 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)	Ketamine Co-Administered With Propofol Ketamine Co-administered with Propofol: 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
Overall Study STARTED	99	84
Overall Study COMPLETED	99	84
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department

Baseline characteristics by cohort

Measure	Ketamine Alone n=99 Participants	Ketamine Co-Administered With Propofol n=84 Participants	Total n=183 Participants Total of all reporting groups
Age, Categorical <=18 years	99 Participants n=5 Participants	84 Participants n=7 Participants	183 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	54 Participants n=7 Participants	128 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants	62 Participants n=7 Participants	134 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	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	99 participants n=5 Participants	84 participants n=7 Participants	183 participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment through completion of follow-up, up to 7 days

Population: Adverse events

We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.

Outcome measures

Measure	Ketamine Alone n=99 Participants	Ketamine Co-Administered With Propofol n=84 Participants
Frequency of Adverse Events Respiratory depression	12 participants	15 participants
Frequency of Adverse Events Cardiovascular event	1 participants	0 participants
Frequency of Adverse Events vomiting/retching	21 participants	18 participants
Frequency of Adverse Events Unpleasant recovery reaction	4 participants	2 participants

SECONDARY outcome

Timeframe: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour

Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.

Outcome measures

Measure	Ketamine Alone n=99 Participants	Ketamine Co-Administered With Propofol n=84 Participants
Recovery Time	44 minutes Interval 19.0 to 69.0	43.5 minutes Interval 17.5 to 67.5

SECONDARY outcome

Timeframe: After procedure is completed, on average less than 1 hour

Efficacy is defined as:

1. The patient does not have unpleasant recall of the procedure.

2. The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged emergency department (ED) observation

3. The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint.

4. The procedure was successful

Outcome measures

Measure	Ketamine Alone n=99 Participants	Ketamine Co-Administered With Propofol n=84 Participants
Efficacy of Sedation	97 participants	81 participants

SECONDARY outcome

Timeframe: After procedure is completed, on average less than 1 hour

Measured on a 10-point scale (1= least satisfied, 10= most satisfied)

Outcome measures

Measure	Ketamine Alone n=99 Participants	Ketamine Co-Administered With Propofol n=84 Participants
Parent Satisfaction	10 units on a scale (1-10) Interval 9.0 to 10.0	10 units on a scale (1-10) Interval 8.0 to 10.0

SECONDARY outcome

Timeframe: After procedure is completed, on average less than 1 hour

Measured on a 10-point scale (1= least satisfied, 10= most satisfied)

Outcome measures

Measure	Ketamine Alone n=99 Participants	Ketamine Co-Administered With Propofol n=84 Participants
Physician Performing Procedure Satisfaction	9 units on a scale Interval 7.0 to 10.0	8 units on a scale Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: After procedure is completed, on average less than 1 hour

Measured on a 10-point scale (1= least satisfied, 10= most satisfied)

Outcome measures

Measure	Ketamine Alone n=99 Participants	Ketamine Co-Administered With Propofol n=84 Participants
Nurse Satisfaction	10 units on a scale Interval 8.0 to 10.0	8 units on a scale Interval 4.0 to 10.0

Adverse Events

Ketamine Alone

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Ketamine Co-Administered With Propofol

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ketamine Alone n=99 participants at risk	Ketamine Co-Administered With Propofol n=84 participants at risk
Respiratory, thoracic and mediastinal disorders Respiratory depression	12.1% 12/99 • Number of events 12	17.9% 15/84 • Number of events 15
Gastrointestinal disorders Vomiting	21.2% 21/99 • Number of events 21	21.4% 18/84 • Number of events 18
Cardiac disorders Cardiovascular event	1.0% 1/99 • Number of events 1	0.00% 0/84
Psychiatric disorders Unpleasant recovery Reaction	4.0% 4/99 • Number of events 4	2.4% 2/84 • Number of events 2

Additional Information

Keith Weisz

Ucolorado

Phone: 303-724-2592

Email: keith.weisz@childrenscolorado.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place