Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

PHASE4CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
FractureDislocation
Interventions
DRUG

Procedural sedation with ketamine-propofol combination

"K= Kétamine P= Propofol RSS= Ramsay Sedation Score~At t0: 0.5 mg/kg of K (0.1 ml/kg of 5 mg/ml K) followed by 0.5 mg/k of P (0.1 ml/kg of 5 mg/ml P).~At t0 + 4 min, if needed to obtain an optimal sedation (RSS of 4 or 5): 0.25 mg/kg of K (0.05 ml/kg of 5 mg/ml K) followed by 0.25 mg/kg of P (0.05 ml/kg of 5 mg/ml P).~At t0 + 8 min, if needed to obtain an optimal sedation (RSS of 4 or 5): 0.25 mg/kg of K (0.05 ml/kg of 5 mg/ml K) followed by 0.25 mg/kg of P (0.05 ml/kg of 5 mg/ml P).~At t0 + 12 min, if maximal doses have been reached (1 mg/kg of K + 1 mg/kg of P) but the optimal sedation has not been obtained, the procedural sedation will be recorded as a failure in the analysis, and the patient will receive another procedural sedation product (at the discretion of the caregiver)."

DRUG

Procedural sedation with ketamine alone

"K= Ketamine I= Intralipid placebo~At t0: 1 mg/kg of K (0.1 ml/kg of 10 mg/ml K), followed by 0.1 ml/kg of I (physical placebo of propofol in the other arm).~At t0 + 4 min, if needed to obtain an optimal sedation (Ramsay Sedation Score of 4 or 5): 0.5 mg/kg of K (0.05 ml/kg of 10 mg/ml K), followed by 0.05 ml/kg of I.~At t0 + 8 min, if needed to obtain an optimal sedation (Ramsay Sedation Score of 4 or 5): 0.5 mg/kg of K (0.05 ml/kg of 10 mg/ml K), followed by 0.05 ml/kg of I.~At t0 + 12 min, if maximal doses have been used (2 mg/kg of K) but the optimal sedation has not been obtained, the procedural sedation will be recorded as a failure in the analysis, and the patient will receive another procedural sedation product (at the discretion of the caregiver)."

Trial Locations (1)

06006

Hôpital St Roch, Nice

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nice

OTHER

NCT01544725 - Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults | Biotech Hunter | Biotech Hunter