Overview

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

Status:
Completed
Trial end date:
2017-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Tehran University of Medical Sciences
Treatments:
Haloperidol
Haloperidol decanoate
Ketamine
Midazolam
Criteria
Inclusion Criteria:

- adult patient older than 18, who need to sedate in Emergency Department

Exclusion Criteria:

- age younger than 18 years,

- patients with significant cardiovascular disease,congestive heart failure (CHF)

- central nervous system lesions or injuries, increased intracranial pressure (ICP)

- ocular pathology, increased intraocular pressure (IOP)

- thyroid disease,

- acute pulmonary infections,

- conditions requiring stimulation of the posterior pharynx,

- had ingested solid food in the previous 4 hours or clear liquids in the previous 2
hours.

- Acute intermittent porphyria

- Alcoholism

- Hepatic Impairment

- Myasthenia gravis

- Respiratory depression

- allergy to haloperidol as established by direct questioning of family members and
available medical history,

- moderate to severe dementia as documented by medical history,

- Parkinson's disease,

- corrected QTc interval (QTc) greater than 500 ms,

- usage of drugs prolonging QT-interval,

- history of torsades de pointes,

- history of neuroleptic malignant syndrome,

- family history of dystonic reactions to drugs,

- epilepsy or history of seizures

- chronic psychiatric disease,

- intoxication

- bone marrow suppression

- pregnancy