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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Ketamine Induced Agitation

Treatments: Drug: Ketamine; Drug: placebo; Drug: Midazolam; Drug: Haloperidol

Study type: Interventional

Funder types: Other

Identifiers

NCT02909465

TehranUMS-ketamine

Details and patient eligibility

About

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.

Full 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).

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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185 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

To do procedural sedation and analgesia in this group, the patients will receive 2 intravenous injections of distilled water (one 2 ml and the other 0.05 cc/kg) 5 minutes before receiving a sedative dose of 1 mg/kg IV ketamine.

Treatment:

Drug: placebo

Drug: Ketamine

midazolam

Experimental group

Description:

To do procedural sedation and analgesia in this group, the patients will receive 2 intravenous injections. one will be 2 ml of distilled water and the other 0.05 mg/kg midazolam, 5 minutes before receiving a sedative dose of 1 mg/kg IV ketamine.

Treatment:

Drug: Midazolam

Drug: placebo

Drug: Ketamine

haloperidol

Experimental group

Description:

To do procedural sedation and analgesia in this group, the patients will receive 2 intravenous injections. One will be 0.05 cc/kg of distilled water and the other 5 mg of haloperidol (in 2 cc syringes), 5 minutes before receiving a sedative dose of 1 mg/kg IV ketamine.

Treatment:

Drug: Haloperidol

Drug: placebo

Drug: Ketamine