NCT01544725: Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

Summary

Using Ketamine for procedural sedation in adults is often uncomfortable for emergency physicians because of the significant proportion of patients experimenting recovery agitation. The investigators believe that combining propofol to ketamine, the proportion of recovery agitation will be significantly lowered. The objectives of this double-blinded, randomized controlled trial are to compare the proportion of recovery agitation in adults receiving procedural sedation with ketamine-propofol versus ketamine alone, and to compare the proportion of other classical procedural sedation side-effects and parameters such as respiratory depression, hypotension, sedation duration, time of recovery, procedural failures, and levels of satisfaction.

Timeline

Start: 2012-04
Primary completion: 2016-01
Completion: 2016-01

Outcome

Met primary endpoint

paper Compared with ketamine, ketofol determined a 22% reduction in recovery reactions incidence (p < 0.01) PMID 28493642 ↗

Publications

Results Lemoel F, Contenti J, Giolito D, Boiffier M, Rapp J, Istria J, Fournier M, Ageron FX, Levraut J. Adverse Events With Ketamine Versus Ketofol for Procedural Sedation on Adults: A Double-blind, Randomized Controlled Trial. Acad Emerg Med. 2017 Dec;24(12):1441-1449. doi: 10.1111/acem.13226. Epub 2017 Jul 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketamine	Small molecule	0.5 mg/kg	—
Subject	Ketamine	Small molecule	1 mg/kg	—
Subject	Propofol	Small molecule	0.5 mg/kg	—

Indications

No indication recorded.