A Comparison of Midazolam or Haloperidol Premedication Versus Placebo for Reducing Ketamine Induced Agitation After Adult Procedural Sedation in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- agitation
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patient older than 18, who need to sedate in Emergency Department
排除标准
- •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
研究组 & 干预措施
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.
干预措施: placebo (Drug)
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.
干预措施: Ketamine (Drug)
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.
干预措施: Midazolam (Drug)
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.
干预措施: placebo (Drug)
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.
干预措施: Ketamine (Drug)
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.
干预措施: Haloperidol (Drug)
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.
干预措施: placebo (Drug)
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.
干预措施: Ketamine (Drug)
结局指标
主要结局
agitation
时间窗: 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
时间窗: 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.
次要结局
- clinician's satisfaction(starts at the time of Ketamine injection through recovery period(maximum of 2 hours))
研究者
Pooya Payandemehr
assistant professor of emergency medicine
Tehran University of Medical Sciences