NCT00684112

Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Scoliosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2008-05-26
• Last updated: 2018-09-18

Locations

1 site across 1 country: Canada