Ketamine Induced Agitation
Conditions
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).
Interventions
DRUGMidazolam
Using Midazolam as a premedication for reducing ketamine-induced agitation
DRUGHaloperidol
Using Haloperidol as a premedication for reducing ketamine-induced agitation
DRUGplacebo
distilled water
DRUGKetamine
Ketamine is routinely used for all procedural sedation in the patients.
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| agitation | starts at the time of Ketamine injection through recovery period(maximum of 2 hours) | 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. |
| level of sedation | 5 minutes after Ketamine injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinician's satisfaction | starts at the time of Ketamine injection through recovery period(maximum of 2 hours) | assessed by a Clinician Satisfaction with Sedation Instrument(CSSI) questionnaire |
Countries
Iran
Outcome results
None listed