drugset / Trial / NCT02909465

Reducing Ketamine-Induced Agitation, by Midazolam or Haloperidol Premedication After Adult Procedural Sedation

NCT02909465

Phase 4 Completed 185 enrolled Tehran University of Medical Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Ketamine is the cornerstone of procedural sedation in emergency department but ketamine induced agitation has limited its usage by many physicians. As a solution, some propose using midazolam or haloperidol before ketamine injection. In this randomized double blind clinical trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. In first group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1 mg/kg). The patients are assessed for agitation during and after the procedure the clinician's satisfaction with sedation instrument is evaluated after the procedure.

Timeline

Start
2016-07
Primary completion
2017-04
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Haloperidol Other / unclassified 5 mg Intravenous
Subject Midazolam Small molecule 0.05 mg/kg Intravenous
Background Ketamine Small molecule 1 mg/kg Intravenous

Indications

No indication recorded.