Clinical Trial: Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary:

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.


Sponsor: The Hospital for Sick Children

Current Primary Outcome: Total morphine consumption postoperatively. [ Time Frame: 0 to 24 hours postoperatively ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to first rescue analgesia. [ Time Frame: Determined by outcome ]
  • 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. ]
  • 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. ]
  • Time to first postoperative oral intake as a measure of bowel function. [ Time Frame: Determined by outcome ]


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: May 22, 2008
Date Started: May 2008
Date Completion:
Last Updated: August 15, 2013
Last Verified: August 2013