A Comparative Evaluation Of Intranasal Dexmedetomidine & Intranasal Midazolam For Premedication In Children A Double Blind Randomised Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- satisfactory sedation score achieved at the time of induction
研究概览
简要总结
**OBJECTIVES:**The study aimed at comparing the efficacies of intranasal dexmedetomidine &intranasal midazolam regarding producing sedation at induction. The secondaryend- points were preoperative heart rate & systolic bloos pressure changesafter administration of either drugs. We also looked at sedation &analgesia status at the time of induction, recovery as well as 3 hours & 6hours post operatively.
**METHODS:**Study subjects comprised of children aged 2-8 years posted for elective surgeryunder general anesthesia. It was a double blind randomized control trialcomprising of 90 subjects divided into 2 groups. group A (n=42) received 0.2μg/kg dexmedetomidine & group B (n=48) 0.5 mg/kg midazolam by intranasalroute 45 minutes prior to induction. sedation & analgesia scores wereassessed by Ramsay Sedation Scale & Observer Pain Scale respectively. heartrate & systolic blood pressures were recorded every 15 minutes pre-operatively after administration of drugs. sedation & analgesia scores wererecorded at induction, recovery, after 3 hours & 6 hours post operatively.
**RESULTS:**93% subjects in group A & 60% in group B achieved satisfactory sedation atthe time of induction. Sedation status & analgesia obtained at the time ofinduction, recovery, 3 hours & 6 hours post operatively were significantlybetter in group A. Pre- operative changes in HR & SBP in both groups werecomparable.
**CONCLUSION:**Intranasal dexmedetomidine is safe &more effectivethan intranasal midazolam for pre operative sedation in children. Also,intranasal dexmedetomidine is a superior agent than intranasal midazolam forpost operative analgesia in pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 8.00 Year(s)(—)
- 性别
- All
入选标准
- •Children aged 2-8 yrs belonging to ASA physical status I or II scheduled for elective surgery.
排除标准
- 未提供
结局指标
主要结局
satisfactory sedation score achieved at the time of induction
时间窗: 45 mins after administration of drug
次要结局
未报告次要终点
