A Phase 3 interventional study of Gabapentin and Placebo in Scoliosis, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-09-18.
Sponsored by The Hospital for Sick Children · Phase 3, Interventional, and Treatment
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.
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 35 is below the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Single dose preoperative gabapentin
Drug: Gabapentin
Single dose preoperative placebo control
Drug: Placebo
Patients in this arm of the study will receive two identical capsules, containing 300 mg of oral gabapentin each, 1 hour before surgery.
Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.
Total morphine consumption postoperatively.
Time frame: 0 to 24 hours postoperatively
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
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children