Analgesic Effects of Gabapentin After Scoliosis Surgery in Children
Recruitment status was Recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Analgesic Effects of Gabapentin After Scoliosis Surgery in Children |
- Total morphine consumption postoperatively. [ Time Frame: 0 to 24 hours postoperatively ] [ Designated as safety issue: No ]
- Time to first rescue analgesia. [ Time Frame: Determined by outcome ] [ Designated as safety issue: No ]
- Pain intensity scores at rest and with movement [ Time Frame: Assessed at 1 hour, 4 hours, 12 hours, 24 hours, 72 hours, and 1 week postoperatively and at the 6-week outpatient follow up visit. ] [ Designated as safety issue: No ]
- Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, and presence of persisting pain symptoms [ Time Frame: Assessed at 1 hour, 4 hours, 12 hours, 24 hours, and 48 hours postoperatively. ] [ Designated as safety issue: No ]
- Time to first postoperative oral intake as a measure of bowel function. [ Time Frame: Determined by outcome ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Experimental: 1 |
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.
|
| Placebo Comparator: 2 |
Drug: Placebo
Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.
|
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.
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
No publications provided
| Responsible Party: | Dr. Arie Peliowski/Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00684112 History of Changes |
| Other Study ID Numbers: | 1000010379 |
| Study First Received: | May 22, 2008 |
| Last Updated: | May 22, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
pediatrics Scoliosis Gabapentin |
Additional relevant MeSH terms:
|
Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases Analgesics Gabapentin Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on June 18, 2013