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

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.

Timeline

Start

2016-07

Primary completion

2017-04

Completion

2017-07

Outcome

Met primary endpoint

paper The maximum Pittsburgh Agitation Scale score was significantly less with midazolam compared with placebo PMID 30611640 ↗

paper Conclusion: For adult procedural sedation, premedication with either midazolam 0.05 mg/kg or haloperidol 5 mg intravenously significantly reduces ketamine-induced recovery agitation while delaying recovery. PMID 30611640 ↗

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Haloperidol	Other / unclassified	5 mg	Intravenous
Subject	Midazolam	Small molecule	0.05 mg/kg	Intravenous
Background	Ketamine	Small molecule	1 mg/kg	Intravenous

Indications

No indication recorded.