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临床试验/CTRI/2018/04/013123
CTRI/2018/04/013123进行中(未招募)4 期

A Comparative Evaluation Of Intranasal Dexmedetomidine & Intranasal Midazolam For Premedication In Children A Double Blind Randomised Control Trial

R G Kar Medical College Hospital Kolkata1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年4月26日最近更新:

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

研究者

发起方
R G Kar Medical College Hospital Kolkata
申办方类型
Government medical college

研究点 (1)

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