Trial Outcomes & Findings for Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED) (NCT NCT00997321)

Results Overview

binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 \>10 or an absence on capnographic waveform

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)

Results posted on

2012-04-02

Participant Flow

100 patients recruited in the Emergency Department

97 enrolled subjects underwent procedural sedation

Participant milestones

Participant milestones
Measure	Propofol propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation	Ketamine ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
Overall Study STARTED	50	50
Overall Study COMPLETED	50	47
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Propofol propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation	Ketamine ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
Overall Study did not undergo sedation after enrollmen	0	3

Baseline Characteristics

Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propofol n=50 Participants propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation	Ketamine n=50 Participants ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	34 years STANDARD_DEVIATION 5 • n=5 Participants	30 years STANDARD_DEVIATION 5 • n=7 Participants	32 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)

Population: 50 subjects were randomized to each group, 50 subjects in the propofol arm completed the study, 47 in the ketamine arm

binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 \>10 or an absence on capnographic waveform

Outcome measures

Outcome measures
Measure	Propofol n=50 Participants percentage of participants with respiratory depression	Ketamine n=47 Participants percentage of participants with respiratory depression
Respiratory Depression (Sub-clinical and Clinical Signs)	0.4 percentage of participants Interval 0.26 to 0.55	0.6 percentage of participants Interval 0.45 to 0.74

SECONDARY outcome

Timeframe: from start of procedure until the return of baseline mental status up to 120 minutes

Population: 50 patients were randomized to the propofol group and 50 to ketamine, 50 underwent the procedure in the propofol group and 47 in the ketamine group

time in seconds from the first dose of medication until the patient has regained baseline mental status

Outcome measures

Outcome measures
Measure	Propofol n=50 Participants percentage of participants with respiratory depression	Ketamine n=47 Participants percentage of participants with respiratory depression
Time to Return of Baseline Mental Status	5 minutes Interval 4.0 to 6.0	14 minutes Interval 10.0 to 29.0

SECONDARY outcome

Timeframe: single measurement immediately after patient returns to baseline mental status after sedation procedure

Population: 100 patients were randomized, 50 to each group, 50 underwent the procedure in the propofol group and 47 in the ketamine group

patient completed question after return to baseline mental status "did you feel pain during the procedure" and "do you remember any part of the procedure" answered by circling yes or no on a question sheet, positive if yes to either question

Outcome measures

Outcome measures
Measure	Propofol n=50 Participants percentage of participants with respiratory depression	Ketamine n=47 Participants percentage of participants with respiratory depression
Patient Reported Pain or Recall of the Procedure	0.06 percentage of participants Interval 0.01 to 0.17	0.02 percentage of participants Interval 0.001 to 0.11

SECONDARY outcome

Timeframe: single measurement during sedation procedure

Population: 100 patients were randomized, 50 to the propofol group, 50 of whom underwent sedation, and 50 in the ketamine group, 47 of whom underwent sedation

Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain

Outcome measures

Outcome measures
Measure	Propofol n=50 Participants percentage of participants with respiratory depression	Ketamine n=47 Participants percentage of participants with respiratory depression
Depth of Sedation	2 score on a scale Interval 1.0 to 4.0	2 score on a scale Interval 1.0 to 4.0

Adverse Events

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Miner

MinneapolisMRF

Phone: 612-873-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place