Sina Hospital
Tehran, Iran
NCT Number: NCT02909465
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Tehran, Iran
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Using Midazolam as a premedication for reducing ketamine-induced agitation
Other names: verdes
Using Haloperidol as a premedication for reducing ketamine-induced agitation
Other names: haldol
distilled water
Ketamine is routinely used for all procedural sedation in the patients.
Other names: ketalar
Time frame: 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.
Time frame: 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.
Time frame: 15 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.
Time frame: 30 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.
Time frame: starts at the time of Ketamine injection through recovery period(maximum of 2 hours)
assessed by a Clinician Satisfaction with Sedation Instrument(CSSI) questionnaire
Tehran University of Medical Sciences
Other
A Comparison of Midazolam or Haloperidol Premedication Versus Placebo for Reducing Ketamine Induced Agitation After Adult Procedural Sedation in the Emergency Department
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