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

NCT02909465 | Completed Phase 4 DMC

• 1 other identifier: TehranUMS-ketamine
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ketamine Induced Agitation

Outcome Measures

Primary Outcomes (4)

• 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)

• 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

• 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

• 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 Outcomes (1)

• clinician's satisfaction

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

Study Arms (3)

placebo

PLACEBO COMPARATOR

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.

Drug: placebo; Drug: Ketamine

midazolam

EXPERIMENTAL

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.

Drug: Midazolam; Drug: placebo; Drug: Ketamine

haloperidol

EXPERIMENTAL

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.

Drug: Haloperidol; Drug: placebo; Drug: Ketamine

Interventions

Midazolam DRUG

Using Midazolam as a premedication for reducing ketamine-induced agitation

Also known as: verdes

midazolam

Haloperidol DRUG

Using Haloperidol as a premedication for reducing ketamine-induced agitation

Also known as: haldol

haloperidol

placebo DRUG

distilled water

haloperidol; midazolam; placebo

Ketamine DRUG

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

Also known as: ketalar

haloperidol; midazolam; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Sina Hospital

Tehran, Iran

Location

Related Publications (5)

• 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.

  PMID: 20970888 BACKGROUND

• 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.

  PMID: 18660398 BACKGROUND

• 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. doi: 10.12816/0003231. Epub 2013 May 9.

  PMID: 23862031 BACKGROUND

• 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. doi: 10.1111/j.1553-2712.2000.tb01064.x.

  PMID: 10730829 BACKGROUND

• Akhlaghi N, Payandemehr P, Yaseri M, Akhlaghi AA, Abdolrazaghnejad A. Premedication With Midazolam or Haloperidol to Prevent Recovery Agitation in Adults Undergoing Procedural Sedation With Ketamine: A Randomized Double-Blind Clinical Trial. Ann Emerg Med. 2019 May;73(5):462-469. doi: 10.1016/j.annemergmed.2018.11.016. Epub 2019 Jan 3.

  PMID: 30611640 DERIVED

MeSH Terms

Interventions

Midazolam; Haloperidol; Ketamine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Butyrophenones; Ketones; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of emergency medicine

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: September 21, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-03

Locations

IR (1)