NCT02909465

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

A Comparison of Midazolam or Haloperidol Premedication Versus Placebo for Reducing Ketamine Induced Agitation After Adult Procedural Sedation in the Emergency Department

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The investigator will fill standard questionnaires for agitation assessment (Richmond Agitation-Sedation Scale and Pittsburgh Agitation Scale).

Conditions

• Ketamine Induced Agitation

Interventions

Type	Name	Description
DRUG	Midazolam	Using Midazolam as a premedication for reducing ketamine-induced agitation
DRUG	Haloperidol	Using Haloperidol as a premedication for reducing ketamine-induced agitation
DRUG	placebo	distilled water
DRUG	Ketamine	Ketamine is routinely used for all procedural sedation in the patients.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-04-01
• Completion: 2017-07-01
• First posted: 2016-09-21
• Last updated: 2017-11-07

Locations

1 site across 1 country: Iran