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

Ketamine Induced Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909465
• Other study ID #: TehranUMS-ketamine
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2016
• Last updated: November 4, 2017
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2017
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ketamine Induced Agitation
• Psychomotor Agitation

Intervention

Drug:
• Midazolam
Using Midazolam as a premedication for reducing ketamine-induced agitation
• Haloperidol
Using Haloperidol as a premedication for reducing ketamine-induced agitation
• placebo
distilled water
• Ketamine
Ketamine is routinely used for all procedural sedation in the patients.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Sina Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (4)

Amr MA, Shams T, Al-Wadani H. Does haloperidol prophylaxis reduce ketamine-induced emergence delirium in children? Sultan Qaboos Univ Med J. 2013 May;13(2):256-62. Epub 2013 May 9. — View Citation

Chudnofsky CR, Weber JE, Stoyanoff PJ, Colone PD, Wilkerson MD, Hallinen DL, Jaggi FM, Boczar ME, Perry MA. A combination of midazolam and ketamine for procedural sedation and analgesia in adult emergency department patients. Acad Emerg Med. 2000 Mar;7(3):228-35. — View Citation

Newton A, Fitton L. Intravenous ketamine for adult procedural sedation in the emergency department: a prospective cohort study. Emerg Med J. 2008 Aug;25(8):498-501. doi: 10.1136/emj.2007.053421. — View Citation

Sener S, Eken C, Schultz CH, Serinken M, Ozsarac M. Ketamine with and without midazolam for emergency department sedation in adults: a randomized controlled trial. Ann Emerg Med. 2011 Feb;57(2):109-114.e2. doi: 10.1016/j.annemergmed.2010.09.010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	agitation	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.	starts at the time of Ketamine injection through recovery period(maximum of 2 hours)
Primary	level of sedation	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.	5 minutes after Ketamine injection
Primary	level of sedation	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.	15 minutes after Ketamine injection
Primary	level of sedation	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.	30 minutes after Ketamine injection
Secondary	clinician's satisfaction	assessed by a Clinician Satisfaction with Sedation Instrument(CSSI) questionnaire	starts at the time of Ketamine injection through recovery period(maximum of 2 hours)