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Completed

NCT Number: NCT02909465

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sina Hospital

Tehran, Iran

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Using Midazolam as a premedication for reducing ketamine-induced agitation

Other names: verdes

Haloperidol

Drug

Using Haloperidol as a premedication for reducing ketamine-induced agitation

Other names: haldol

Placebo

Drug

distilled water

ketamine

Drug

Ketamine is routinely used for all procedural sedation in the patients.

Other names: ketalar

Primary outcomes

  1. agitation

    Time frame: starts at the time of Ketamine injection through recovery period(maximum of 2 hours)

    assessed by Pittsburgh Agitation Scale(scoring 0 to 16).

    Pittsburgh Agitation Scale(scoring 0 to 16) is a valid and reliable instrument to assess agitation severity of inpatients.

  2. level of sedation

    Time frame: 5 minutes after Ketamine injection

    assessed by Richmond Agitation-Sedation Scale(scoring -5 to +4).

    Richmond Agitation-Sedation Scale(scoring -5 to +4) is a valid and reliable instrument to assess level of sedation and agitated behavior during sedation.

  3. level of sedation

    Time frame: 15 minutes after Ketamine injection

    assessed by Richmond Agitation-Sedation Scale(scoring -5 to +4).

    Richmond Agitation-Sedation Scale(scoring -5 to +4) is a valid and reliable instrument to assess level of sedation and agitated behavior during sedation.

  4. level of sedation

    Time frame: 30 minutes after Ketamine injection

    assessed by Richmond Agitation-Sedation Scale(scoring -5 to +4).

    Richmond Agitation-Sedation Scale(scoring -5 to +4) is a valid and reliable instrument to assess level of sedation and agitated behavior during sedation.

Secondary outcomes

  1. clinician's satisfaction

    Time frame: starts at the time of Ketamine injection through recovery period(maximum of 2 hours)

    assessed by a Clinician Satisfaction with Sedation Instrument(CSSI) questionnaire

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.