Analgesic Effects of Gabapentin After Scoliosis Surgery in Children
Overview[ - collapse ][ - ]
| Purpose | The primary aim of this study is to determine whether the use of gabapentin will improve postoperative analgesia and reduce opioid consumption and side effects in children undergoing corrective spinal surgery for idiopathic scoliosis. Secondary aims are to evaluate whether use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases persisting pain and improves patient satisfaction. |
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| Condition | Scoliosis |
| Intervention | Drug: Gabapentin Drug: Placebo |
| Phase | Phase 3 |
| Sponsor | The Hospital for Sick Children |
| Responsible Party | The Hospital for Sick Children |
| ClinicalTrials.gov Identifier | NCT00684112 |
| First Received | May 22, 2008 |
| Last Updated | August 15, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 22, 2008 |
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| Last Updated Date | August 15, 2013 |
| Start Date | May 2008 |
| Estimated Primary Completion Date | February 2010 |
| Current Primary Outcome Measures | Total morphine consumption postoperatively. [Time Frame: 0 to 24 hours postoperatively] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Analgesic Effects of Gabapentin After Scoliosis Surgery in Children |
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| Official Title | Analgesic Effects of Gabapentin After Scoliosis Surgery in Children |
| Brief Summary | The primary aim of this study is to determine whether the use of gabapentin will improve postoperative analgesia and reduce opioid consumption and side effects in children undergoing corrective spinal surgery for idiopathic scoliosis. Secondary aims are to evaluate whether use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases persisting pain and improves patient satisfaction. |
| Detailed Description | Surgical correction of scoliosis involves major orthopedic surgery, and can lead to severe acute postoperative pain and persistent neuropathic pain. The mainstays of treating postoperative pain are acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), systemic opioids, and local anesthetic techniques. Despite being effective, their use is limited by adverse side effects. Acute postoperative pain involves multiple mechanisms and neural pathways, therefore a combination of different analgestic medications acting through different mechanisms, may be the most effective treatment. This strategy may also reduce the need for, and side effects of, using high doses of any one particular class of drugs. Gabapentin is safe and well tolerated with few side effects and has minimal interactions with other drugs. The use of gabapentin to treat acute postoperative pain may improve quality of analgesia, result in decreased requirements for opioids and might consequently reduce the incidence of opioid induced side effects. It may also have a direct effect on postoperative nausea and vomiting, and decrease the incidence of persistent neuropathic pain. These qualities make gabapentin an attractive agent for use in management of postoperative pain in children undergoing corrective spinal injury. The primary aim of this study is to determine whether the use of gabapentin will improve postoperative analgesia and reduce opioid consumption and side effects in children undergoing corrective spinal surgery for idiopathic scoliosis. Secondary aims are to evaluate whether use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases persisting pain and improves patient satisfaction. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Scoliosis |
| Intervention | Drug: Gabapentin Patients in this arm of the study will receive two identical capsules, containing 300 mg of oral gabapentin each, 1 hour before surgery. Drug: Placebo Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
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| Estimated Enrollment | 35 |
| Estimated Completion Date | February 2010 |
| Estimated Primary Completion Date | December 2009 |
| Eligibility Criteria | Inclusion Criteria: - 10 - 17 years of age - scheduled for elective surgical correction of scoliosis - able to operate a patient-controlled analgesia (PCA) pump Exclusion Criteria: - unable to cooperate - unable to operate the PCA pump - unable to rate pain - have a known allergy or sensitivity to gabapentin or morphine - have a history of chronic pain or daily analgesic use - have taken acetaminophen, a non-steroidal anti-inflammatory drug, or an antacid within a 24-hour period prior to surgery |
| Gender | Both |
| Ages | 10 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00684112 |
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| Other Study ID Numbers | 1000010379 |
| Has Data Monitoring Committee | No |
| Information Provided By | The Hospital for Sick Children |
| Study Sponsor | The Hospital for Sick Children |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Arie Peliowski, MD The Hospital for Sick Children, Toronto Canada |
| Verification Date | August 2013 |
Locations[ + expand ][ + ]
| The Hospital for Sick Children | Toronto, Ontario, Canada, M5G 1X8 |
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