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临床试验/NCT00130091
NCT00130091已完成2 期

The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children

Children's Hospital of Eastern Ontario1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Time to first analgesia after procedure

研究概览

简要总结

The current study will compare the effects on postoperative pain relief of "freezing" (ropivacaine 0.2 %) alone and in combination with clonidine for a nerve block in children undergoing hernia repair. The researchers anticipate that the addition of clonidine to "freezing" will result in prolongation of postoperative pain relief in children undergoing hernia repair compared to "freezing" used alone.

详细描述

The optimal method of controlling postoperative pain in children undergoing hernia repair would effectively relieve pain for extended periods of time and have no adverse effects. Unfortunately, such an ideal technique does not exist.

The control of postoperative pediatric pain after hernia repair is achieved with a combination of oral and intravenous pain medications and "nerve blocks". "Nerve blocks" are achieved by injecting local anesthetics or what is commonly referred to as "freezing "next to the nerve supply of the wound. "Freezing" the major nerves supplying sensation at the site of hernia repair in children, while they are asleep, is effective. At CHEO, this technique in addition to administering ketorolac, a liquid intravenous form of an anti-inflammatory agent similar to Advil, is the current technique of choice for postoperative pain control after inguinal hernia.

It is not unusual for these patients to require extra pain medications postoperatively. Available means of pain control in addition to those mentioned above include codeine-like medications, Tylenol, Advil-like medications and opioids administered intravenously. The addition of these medications increases the risk of suffering from side effects including respiratory depression, nausea and vomiting, and itching.

Ideally, the prolongation of postoperative pain relief by the addition of a second medication to the "freezing" during the nerve block would limit the need for additional pain medication and hence, decrease their associated side effects. Clonidine has the potential to be such a medication. It has been shown to provide pain relief by affecting several areas of the nervous system including the brain, the spinal cord and nerves. Clonidine prolongs pain relief of certain local anesthetics when used in nerve blocks for adults. Unfortunately, there are no studies that have examined the combination of clonidine and the local anesthetic ropivacaine for nerve blocks in children. Presently, the injectable form of clonidine is not marketed and is considered investigational in Canada.

The current study will be a prospective double -blind, randomized, controlled trial. It will compare the effects on postoperative pain relief of "freezing" (ropivacaine 0.2 %) alone and in combination with clonidine for a nerve block in children undergoing hernia repair. In addition, it will measure changes in the child's level of sedation, breathing, heart rate, blood pressure and any complications. Finally, it will assess how satisfied the parents are with this technique.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Unilateral inguinal hernia or hydrocele
  • 1 to 12 years old
  • American Society of Anesthesiology classification I-II
  • Written informed consent

排除标准

  • Exclusion to nerve block
  • Clotting disorder
  • Infection
  • Known allergy to clonidine or ropivacaine
  • History of chronic, therapeutic administration of analgesics
  • Receiving medications for attention deficit hyperactivity disorder
  • Patients taking oral clonidine
  • Undergoing bilateral hernia repair
  • Morbid obesity

研究组 & 干预措施

Local anesthetic

Placebo Comparator

Local anesthetic without clonidine

干预措施: clonidine (Drug)

Clonidine

Experimental

administer with local anesthetic

干预措施: clonidine (Drug)

结局指标

主要结局

Time to first analgesia after procedure

时间窗: 24 hours

次要结局

  • continuous pain scores (modified Children's Hospital of Eastern Ontario Pain Score [mCHEOPS], modified Wong-Baker Faces)(baseline plus seven days)
  • total analgesics consumed(seven days)
  • total sedation consumed(Between surgery and surgical day unit discharge (approx four hours))
  • sedation scores(Between surgery and surgical day unit discharge (approx four hours))
  • emergence delirium score (Pediatric Anesthesia Emergence Delirium [PAED])(Between surgery and surgical day unit discharge (approx four hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kimmo Murto

MD, FRCPC, Dept. Anesthesiology CHEO, Assistant Professor, University of Ottawa

Children's Hospital of Eastern Ontario

研究点 (1)

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