跳至主要内容
临床试验/CTRI/2025/12/098552
CTRI/2025/12/098552尚未招募Phase 3 4

A comparative study evaluating the incidence of post operative complications with two distinct doses of morphine used as adjuvants in caudal block for paediatric patients undergoing infraumbilical surgical procedures.

AKANKSHA JENA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月25日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

Postoperative pain is a major concern in pediatric patients undergoing infraumbilical surgeries such as herniotomy, orchidopexy, and circumcision. Inadequately managed pain in children can lead to physiological stress responses, delayed recovery, and long term behavioral disturbances. Although infraumbilical surgeries are usually short in duration, effective control of postoperative pain is essential to promote early ambulation, reduce the length of hospital stay, and improve overall patient comfort.

Several analgesic strategies are used in this age group, including systemic medications such as non steroidal anti inflammatory drugs and opioids, as well as regional anesthesia techniques. Among the regional approaches, the caudal block is one of the most commonly performed procedures in pediatric anesthesia. It provides reliable intraoperative and postoperative analgesia for surgeries below the umbilicus, has a high success rate, and offers a favorable safety profile.

To prolong the duration of analgesia from caudal blocks, various adjuvants have been added to local anesthetics. Morphine, a hydrophilic opioid, is one of the most widely used adjuvants in caudal anesthesia. Doses typically range from 10 to 30 micrograms per kilogram and have been shown to extend postoperative pain relief for 12 to 24 hours. However, higher doses of caudal morphine are known to increase the risk of adverse effects including postoperative nausea and vomiting, pruritus, urinary retention, and in rare cases respiratory depression. Recent investigations comparing lower and standard doses have suggested that reducing the dose may maintain analgesic efficacy while minimizing these unwanted effects.

Considering the narrow therapeutic range of caudal morphine in young children, the present study is designed to compare the incidence of postoperative nausea, vomiting, and urinary retention between two doses, 15 micrograms per kilogram and 30 micrograms per kilogram, in children aged one to six years undergoing infraumbilical surgeries. This comparison will help determine whether a lower dose can provide effective analgesia with fewer complications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • ASA I & II patients undergoing infraumbilical surgery.

排除标准

  • Known allergy or hypersensitivity to morphine, ropivacaine, or any local anaesthetic.
  • Infection at the caudal injection site or systemic infection.
  • Bleeding disorders or patients on anticoagulant
  • Chronic respiratory diseases (e.g., severe asthma, obstructive sleep apnea, or any condition predisposing to respiratory depression).
  • Congenital or acquired spinal abnormalities.

研究者

发起方
AKANKSHA JENA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

AKANKSHA JENA

ARMED FORCES MEDICAL COLLEGE, PUNE

研究点 (1)

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