Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 4

Conditions: Dislocation; Fracture

Treatments: Drug: Procedural sedation with ketamine-propofol combination; Drug: Procedural sedation with ketamine alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01544725

11-PP-16

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and older
• indication of procedural sedation

Exclusion criteria

• allergy to propofol or ketamine
• alcohol or drug intoxication
• altered mental status
• ASA physical status score > 2
• hemodynamic unstability

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Ketamine-propofol

Experimental group

Treatment:

Drug: Procedural sedation with ketamine-propofol combination

Ketamine alone

Active Comparator group

Treatment:

Drug: Procedural sedation with ketamine alone