Clinical trial NCT02909465: Reducing Ketamine-Induced Agitation, by Midazolam or Haloperidol Premedication After Adult Procedural Sedation
Official title: A Comparison of Midazolam or Haloperidol Premedication Versus Placebo for Reducing Ketamine Induced Agitation After Adult Procedural Sedation in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ketamine Induced Agitation
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: agitation
timeFrame: starts at the time of Ketamine injection through recovery period(maximum of 2 hours)
measure: level of sedation
timeFrame: 5 minutes after Ketamine injection
measure: level of sedation
timeFrame: 15 minutes after Ketamine injection
measure: level of sedation
timeFrame: 30 minutes after Ketamine injection
Secondary outcomes:
measure: clinician's satisfaction
timeFrame: starts at the time of Ketamine injection through recovery period(maximum of 2 hours)
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Sina Hospital
Study officials:
References:
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.
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.
citation: 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.
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. doi: 10.1111/j.1553-2712.2000.tb01064.x.
citation: 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.