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

NCT ID: NCT02909465

Last Updated: 2017-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-07-31

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.

Detailed 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).

Conditions

Ketamine Induced Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

distilled water

Ketamine

Intervention Type: DRUG

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

midazolam

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.

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

Using Midazolam as a premedication for reducing ketamine-induced agitation

placebo

Intervention Type: DRUG

distilled water

Ketamine

Intervention Type: DRUG

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

haloperidol

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.

Group Type: EXPERIMENTAL

Haloperidol

Intervention Type: DRUG

Using Haloperidol as a premedication for reducing ketamine-induced agitation

placebo

Intervention Type: DRUG

distilled water

Ketamine

Intervention Type: DRUG

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

Interventions

Midazolam

Using Midazolam as a premedication for reducing ketamine-induced agitation

Intervention Type: DRUG

Haloperidol

Using Haloperidol as a premedication for reducing ketamine-induced agitation

Intervention Type: DRUG

placebo

distilled water

Intervention Type: DRUG

Ketamine

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

Intervention Type: DRUG

Other Intervention Names

verdes; haldol; ketalar

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Pooya Payandemehr

assistant professor of emergency medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sina Hospital

Tehran, , Iran

Countries

Iran

References

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.

Reference Type: BACKGROUND

PMID: 20970888 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18660398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23862031 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10730829 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30611640 (View on PubMed)

Other Identifiers

TehranUMS-ketamine

Identifier Type: -

Identifier Source: org_study_id