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| Sponsor: | The Hospital for Sick Children |
|---|---|
| Information provided by: | The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00684112 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Scoliosis |
Drug: Gabapentin Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Analgesic Effects of Gabapentin After Scoliosis Surgery in Children |
| Estimated Enrollment: | 36 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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.
|
| 2: Placebo Comparator |
Drug: Placebo
Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.
|
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.
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Arie Peliowski, MD | 416-813-7654 ext 2455 | arie.peliowski@sickkids.ca |
| Canada, Ontario | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Arie Peliowski, MD 416-813-7654 ext 2455 arie.peliowski@sickkids.ca | |
| Sub-Investigator: Fiona Campbell, MD | |
| Sub-Investigator: Srivivasan Ilavajady, MD | |
| Sub-Investigator: Lori Palozzi, NP | |
| Sub-Investigator: Janet Ahier, NP | |
| Principal Investigator: Arie Peliowski, MD | |
| Principal Investigator: | Arie Peliowski, MD | The Hospital for Sick Children, Toronto Canada |
More Information
| Responsible Party: | The Hospital for Sick Children ( Dr. Arie Peliowski/Principal Investigator ) |
| Study ID Numbers: | 1000010379 |
| Study First Received: | May 22, 2008 |
| Last Updated: | May 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00684112 History of Changes |
| Health Authority: | Canada: Health Canada |
|
pediatrics Scoliosis Gabapentin |
|
Scoliosis Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Bone Diseases Membrane Transport Modulators Musculoskeletal Diseases Sensory System Agents |
Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Spinal Diseases Tranquilizing Agents Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Spinal Curvatures Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |