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临床试验/NCT01679353
NCT01679353已完成不适用

Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair

Yonsei University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
The number of children who required analgesics

研究概览

简要总结

A caudal anesthesia is one of the most commonly used technique providing intra and postoperative analgesia in pediatric low abdominal surgery. The practice of adding adjunct analgesic drugs to local anesthetics for caudal block is common. The most commonly used drugs are opioids, clonidine, and ketamine. However, their use has been limited by adverse effects in children.

Recently, the importance of magnesium in analgesic effects has been increased. Magnesium is the fourth most abundant cation in the body. It has antinociceptive effects in human and these effects are primarily based on the regulation of calcium influx into the cell. Magnesium is a physiological calcium antagonist and blocks N-methyl-D-aspartate (NMDA) receptor and such NMDA antagonism prevents the central sensitization from nociceptive stimulation. Many study suggested that epidurally administered magnesium could reduce the postoperative pain in adults. But few studies are available about the use of magnesium in pediatrics.

The investigators performed prospective randomized double-blind study to examine the analgesic effect of magnesium added to ropivacaine and ropivacaine alone in caudal analgesia on postoperative pain control in pediatric patients undergoing inguinal hernia repair.

80 children (aged 2- 6 yr) undergoing inguinal hernia repair were included in this prospective, randomized, double-blinded study. After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium 50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR. Postoperative pain was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be followed for the duration of hospital stay, an expected average of 3 hours.

After discharge, rescue analgesic consumption, pain scores (Parents Postoperative Pain Measurement, PPPM), and adverse effects were evaluated for 48h.

The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a PPPM( 0 - 15) ≥ 6 by parent's observation. 48 hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA status I-II,
  • children aged 2 to 6 yr
  • weight under 20kg
  • undergoing inguinal hernia repair

排除标准

  • Hypersensitivity fo any local anesthetics,
  • bleeding diathesis, infections at puncture sites,
  • pre-existing neurological disease,
  • patients taking Calcium channel block,
  • patients taking opioid

研究组 & 干预措施

placebo group

Placebo Comparator

normal saline 0.5ml

干预措施: normal saline 0.5ml (Drug)

magnesum group

Experimental

After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium 50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR.

干预措施: caudal block (Drug)

结局指标

主要结局

The number of children who required analgesics

时间窗: at 24 and 48 hours after surgery

Primary outcome is defined as the number of patients who required analgesics after discharge. Postoperative pain at home is assessed by parent using the PPPM scale that consists of 15 questions requiring a "yes" or "no" answer (yes = 1 point and no = 0 point). A PPPM score ≥ 6 by parent's observation is considered to represent clinically significant pain, requiring analgesics. The PPPM is a 15-item observational checklist measure of pain intensity that was designed to be used by parents to support research and clinical postoperative care for children at home.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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