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Analgesic Effects of Gabapentin After Scoliosis Surgery in Children
This study is currently recruiting participants.
Study NCT00684112   Information provided by The Hospital for Sick Children
First Received: May 22, 2008   No Changes Posted

May 22, 2008
May 22, 2008
May 2008
September 2008   (final data collection date for primary outcome measure)
Total morphine consumption postoperatively. [ Time Frame: 0 to 24 hours postoperatively ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Time to first rescue analgesia. [ Time Frame: Determined by outcome ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Time to first postoperative oral intake as a measure of bowel function. [ Time Frame: Determined by outcome ] [ Designated as safety issue: No ]
Same as current
 
Analgesic Effects of Gabapentin After Scoliosis Surgery in Children
Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
Scoliosis
  • 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.
  • 1: Experimental
    Intervention: Drug: Gabapentin
  • 2: Placebo Comparator
    Intervention: Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
36
December 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
10 Years to 17 Years
No
Contact: Arie Peliowski, MD 416-813-7654 ext 2455 arie.peliowski@sickkids.ca
Canada
 
NCT00684112
Dr. Arie Peliowski/Principal Investigator, The Hospital for Sick Children
1000010379
The Hospital for Sick Children
 
Principal Investigator: Arie Peliowski, MD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP