Scoliosis
Conditions
Keywords
pediatrics, Scoliosis, Gabapentin
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 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.
Interventions
DRUGGabapentin
Patients in this arm of the study will receive two identical capsules, containing 300 mg of oral gabapentin each, 1 hour before surgery.
DRUGPlacebo
Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total morphine consumption postoperatively. | 0 to 24 hours postoperatively |
Secondary
| Measure | 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 |
Countries
Canada
Outcome results
None listed