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Tracking Information | |||||
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First Received Date † | August 11, 2005 | ||||
Last Updated Date | September 22, 2005 | ||||
Start Date † | September 2005 | ||||
Current Primary Outcome Measures † |
time to first analgesia | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00130091 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children | ||||
Official Title † | |||||
Brief Summary | 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. |
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Detailed Description | 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
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. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † |
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Intervention † | Drug: clonidine | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Not yet recruiting | ||||
Enrollment † | 128 | ||||
Completion Date | September 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 1 Year to 13 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
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Location Countries † | Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00130091 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Children's Hospital of Eastern Ontario | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Children's Hospital of Eastern Ontario | ||||
Verification Date | August 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |