跳至主要内容
临床试验/CTRI/2018/01/011579
CTRI/2018/01/011579已完成4 期

Comparison of peribulbar block and sub-tenon infiltration in paediatric enucleation of the eye

AIIMS HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年11月1日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Perioperative analgesia following enucleation surgeries in children

研究概览

简要总结

*Enucleation is associated with severe pain in the postoperative period. This pain is commonly treated with opioids and NSAIDS. Sub-tenon & peri-bulbar blocks have been found to be effective analgesic for various ophthalmic surgeries. There is no previous report of use of these blocks for perioperative analgesia in enucleation surgeries.  *Hence we planned this prospective ,controlled clinical trial

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
6.00 Month(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Age ranging from 6months to 6 years ASA Grade I and II.

排除标准

  • Children whose parents are unwilling to give consent.
  • ASA Grade III and IV Children who are mentally retarded or deaf.
  • Children with a history of allergy to local anaesthetics.
  • Significant cardiac, respiratory, hepatic or renal dysfunction.
  • Children with any other intraocular pathology like endophthalmitis or inflammatory diseases.

结局指标

主要结局

Perioperative analgesia following enucleation surgeries in children

时间窗: All children were assessed immediately after surgery then after 1hr, 2hr,3hr,4hr,8hr and 24 hr

次要结局

  • Recovery profile :Time to discharge from PACU (post anesthesia care unit)(Incidence of Side effects : PONV and OCR)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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