Analgesic Effects of Gabapentin After Scoliosis Surgery in Children
Study Overview
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Gabapentin
Single dose preoperative gabapentin
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Patients in this arm of the study will receive two identical capsules, containing 300 mg of oral gabapentin each, 1 hour before surgery.
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PLACEBO_COMPARATOR: Placebo Control
Single dose preoperative placebo control
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Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total morphine consumption postoperatively.
Time Frame: 0 to 24 hours postoperatively
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0 to 24 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to first rescue analgesia.
Time Frame: Determined by outcome
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Determined by outcome
|
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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.
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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.
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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.
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Assessed at 1 hour, 4 hours, 12 hours, 24 hours, and 48 hours postoperatively.
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Time to first postoperative oral intake as a measure of bowel function.
Time Frame: Determined by outcome
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Determined by outcome
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arie Peliowski, MD, The Hospital for Sick Children, Toronto Canada
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Spinal Diseases
- Bone Diseases
- Spinal Curvatures
- Scoliosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Anticonvulsants
- Antimanic Agents
- Gabapentin
Other Study ID Numbers
- 1000010379
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