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临床试验/CTRI/2013/08/003915
CTRI/2013/08/003915招募中Phase 3 4

To compare the efficacy of two different types of analgesic techniques for postoperative pain relief after lower Abdominal and pelvic surgeries in paediatric surgical cases

SPGIMS Lucknow1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年10月26日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
outcome of this study will suggest the most effective method of analgesic technique for providing postoperative pain relief in paediatric surgical cases

研究概览

简要总结

Aim:“To compare the efficacy of two different types of analgesic techniques for postoperative pain relief after lower abdominal and pelvic surgeries in paediatric surgical case

**Justification for the study:-**Here we are trying to study and comparing the efficacy of two different types of analgesic techniques for postoperative pain relief after lower abdominal and pelvic surgeries in paediatric surgical cases.The expected outcome of this study will suggest the most effective method of analgesic technique for providing postoperative pain relief in paediatric surgical cases

methodology**-**we intend to enrol 80 unpremedicated, ASA class- I paediatric surgical patients of either sex (age between 5–16years) undergoing lower abdominal or pelvic surgery will be included in this study; they will be divided into two groups of 40 each using a randomization chart. Group- I, in which the children’s will be operated under general anaesthesia and will be anesthetized in a standard fashion along with preoperative caudal epidural block which will be given following induction of general anaesthesia and intermittent bolus doses of intravenous short acting synthetic opioid (fentanyl) for control of pain sign/symptoms as rescue analgesic. While in Group II  the children’s will be operated under general anaesthesia and will be anesthetized in a standard fashion along with preoperative analgesic suppositories of paracetamol which will be given following induction of general anaesthesia and intermittent bolus doses of intravenous short acting synthetic opioid (fentanyl) for control of pain sign/symptoms as rescue analgesic. All the recruited patients were instructed on proper use of the visual analogue sliding scale (vas scale) system [0= no pain, 100=worst pain imaginable] at the time PAC a day before surgery as well as again on arrival in the induction room. All the patients were randomized to receive any one of the above two mentioned techniques to get  post operative pain relief .The time of injection of drug (via caudal epidural and via rectal route in the form of suppository) is to be  noted and surgical incision will be allowed after at least 15 minutes had been elapsed subsequently. The pain relief would be deemed unsuccessful if there is a  persistant increase of more than 30% in heart rate or mean arterial blood pressure values above baseline following surgical incision. These patients will be given intravenous fentanyl 1microgm/kg and will be withdrawn from the study. At the end of the surgery all anaesthetics will be stopped and 100% oxygen will be administered.

VAS pain scores will be elicited upon emergence from anesthesia,and at 1 ,2and 24hrs postoperatively after injection of analgesic drug (via caudal epidural and via rectal route in the form of suppository) by blinded investigator. Other adverse events such as nausea and vomiting will also be noted.

Rescue medication (i/v fentanyl 1 microgram/kg) has to be administered if the VAS pain score exceeded 50 at any time.  Other parameters to be studied are quality of night sleep, adverse effects of analgesics, recovery of bowel and bladder function, economic impact and morbidity related to the two techniques.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • 1-unpremedicated, 2-ASA class- I paediatric surgical patients of either sex 3-age between 5-16 yrs 4-can able to understand and comprehend the visual analogue Wong-Baker Faces Scale scoring system 5-undergoing lower abdominal or pelvic surgery.

排除标准

  • 1-more than ASA Grade I 2-Age below 5 years and age above 16 years 3-Contraindication to caudal epidural block 4-inability to comprehend the visual analogue Wong-Baker Faces Scale scoring system with visual analogue number rating scoring system.

结局指标

主要结局

outcome of this study will suggest the most effective method of analgesic technique for providing postoperative pain relief in paediatric surgical cases

时间窗: 1, 2, 24 hrs postoperatively

次要结局

  • nausea and vomiting will also be noted.Rescue medication (i/v fentanyl 1 microgram/kg) has to be administered if the VAS pain score exceeded 50 at any time. The times from injection to first unsupported standing after anaesthesia and hospital discharge will also be documented(1, 2, 24 hrs postoperatively)

研究者

发起方
SPGIMS Lucknow
申办方类型
Research institution and hospital

研究点 (1)

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