Comparative study of Intramuscular Midazolam, Lorazepam and Haloperidol-Promethazine combination for management of acute agitation.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Time till adequate sedation using Altered Mental Status Scale (AMSS)
研究概览
简要总结
In the event that the patient meets the study’s eligibility requirements, socio-demographic and clinical profile and the baseline AMSS score will be gathered. CAM would be applied to filter out patients with delirium. Computer generated number will be used for randomization. Each patient would either receive 5mg midazolam or 2mg lorazepam or 5mg haloperidol and 50 mg promethazine combination. Time to adequate sedation (defined as AMSS score less than/equal to 0) will be recorded with a stopwatch. Occurrence of bradycardia (Pulse Rate <60 beats per minute), extrapyramidal adverse effects (akathisia or dystonia), allergic reactions (rash, wheezing, or anaphylaxis), hypoxemia (oxygen saturation <93%), or intubation will also be noted.Patient would be followed up till 12 hours after the intramuscular injection has been given. AMSS score would be calculated at 0, 30 min, 1 hour, 6 hour and 12 hour mark. Blood pressure, pulse rate, oxygen saturation and AIMS score (for extrapyramidal symptoms) would also be noted. In case the patient continues to have disruptive behavior at 30 minutes after first dose, repeat dose of same agent, that is, 5mg midazolam or 2mg lorazepam or 5mg haloperidol and 50 mg promethazine combination, will be considered and documented. If the patient remains disruptive at 1 hour mark or after 2 injections, it will be considered as “failure to sedateâ€, however management will continue as standard care. If repeat dose of sedative is given up till 12 hours after adequate sedation is once achieved, it will be documented. Comparison between 3 subgroups regarding time of adequate sedation and need for repeat sedation will be done. After the end of study period, that is 12 hours, treatment as usual will resume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Altered Mental Status Scale (AMSS) score greater than 1.
排除标准
- •Patient with known allergy of either midazolam or lorazepam or haloperidol or promethazine.
- •Patient with medically reversible cause of agitation (hypotension, hypoxia or hypoglycemia).
- •Patient known to be pregnant or lactating.
- •Patient presenting with drug withdrawals or drug intoxication within past 48 hours.
- •Patient with history of head injury within past 48 hours.
- •Patient in active Delirium.
- •Patient chemically restrained in past 24 hours.
结局指标
主要结局
Time till adequate sedation using Altered Mental Status Scale (AMSS)
时间窗: 0 min, then every 3 minutes till adequate sedation
次要结局
- Need for repeat sedation(0,30 min, 1 hour, 6 hour, 12 hour)
研究者
Lakhwinder Singh
Government Medical College and Hospital, Sector 32, Chandigarh
