Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

Scoliosis Clinical Trial

Official title:

Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684112
• Other study ID #: 1000010379
• Status: Completed
• Phase: Phase 3
• Start date: May 2008
• Est. completion date: February 2010

Study information

• Verified date: September 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

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.
• Placebo
Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption postoperatively.		0 to 24 hours postoperatively
Secondary	Time to first rescue analgesia.		Determined by outcome
Secondary	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.
Secondary	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.
Secondary	Time to first postoperative oral intake as a measure of bowel function.		Determined by outcome

External Links

•   Link to published study results