Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

Condition(s) targeted: Scoliosis

Intervention: Gabapentin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: The Hospital for Sick Children

Official(s) and/or principal investigator(s):
Arie Peliowski, MD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada

Overall contact:
Arie Peliowski, MD, Phone: 416-813-7654, Ext: 2455, Email: arie.peliowski@sickkids.ca

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.

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

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

Primary outcome: Total morphine consumption postoperatively.

Secondary outcome:

Time to first rescue analgesia.

Pain intensity scores at rest and with movement

Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, and presence of persisting pain symptoms

Time to first postoperative oral intake as a measure of bowel function.

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.

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Arie Peliowski, MD, Phone: 416-813-7654, Ext: 2455, Email: arie.peliowski@sickkids.ca

The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Arie Peliowski, MD, Phone: 416-813-7654, Ext: 2455, Email: arie.peliowski@sickkids.ca
Fiona Campbell, MD, Sub-Investigator
Srivivasan Ilavajady, MD, Sub-Investigator
Lori Palozzi, NP, Sub-Investigator
Janet Ahier, NP, Sub-Investigator
Arie Peliowski, MD, Principal Investigator

Starting date: May 2008
Ending date: December 2008
Last updated: May 22, 2008