Official Title: “Analgesic Effects of Gabapentin After Scoliosis Surgery in Children”

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 Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2008

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Total morphine consumption postoperatively.
  • Time Frame: 0 to 24 hours postoperatively
    Safety Issue?: No

Secondary Measures

• Time to first rescue analgesia.
  • Time Frame: Determined by outcome
    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.
    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.
    Safety Issue?: No
• Time to first postoperative oral intake as a measure of bowel function.
  • Time Frame: Determined by outcome
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The Hospital for Sick Children

Overall Clinical Trial Officials and Contacts

Arie Peliowski, MD Principal Investigator The Hospital for Sick Children, Toronto Canada  

Overall Contact: Arie Peliowski, MD 416-813-7654 arie.peliowski@sickkids.ca

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00684112

Study ID Number: 1000010379

ClinicalTrials.gov Identifier: NCT00684112

Health Authority: Canada: Health Canada