Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

Conditions
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Scoliosis

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Single dose preoperative gabapentin | Drug: Gabapentin<br>* Patients in this arm of the study will receive two identical capsules, containing 300 mg of oral gabapentin each, 1 hour before surgery.<br>|
| Placebo Comparator: Placebo Control<br>Single dose preoperative placebo control | Drug: Placebo<br>* Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption postoperatively. |  | 0 to 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first rescue analgesia. |  | Determined by outcome | 
| Pain intensity scores at rest and with movement |  | 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. | 
| Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, and presence of persisting pain symptoms |  | Assessed at 1 hour, 4 hours, 12 hours, 24 hours, and 48 hours postoperatively. | 
| Time to first postoperative oral intake as a measure of bowel function. |  | Determined by outcome | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, Scoliosis, Gabapentin