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

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.


Condition Intervention Phase
Scoliosis
Drug: Gabapentin
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Total morphine consumption postoperatively. [ Time Frame: 0 to 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: May 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental 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.
2: Placebo Comparator Drug: Placebo
Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684112

Contacts
Contact: Arie Peliowski, MD 416-813-7654 ext 2455 arie.peliowski@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Arie Peliowski, MD     416-813-7654 ext 2455     arie.peliowski@sickkids.ca    
Sub-Investigator: Fiona Campbell, MD            
Sub-Investigator: Srivivasan Ilavajady, MD            
Sub-Investigator: Lori Palozzi, NP            
Sub-Investigator: Janet Ahier, NP            
Principal Investigator: Arie Peliowski, MD            
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Arie Peliowski, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: The Hospital for Sick Children ( Dr. Arie Peliowski/Principal Investigator )
Study ID Numbers: 1000010379
Study First Received: May 22, 2008
Last Updated: May 22, 2008
ClinicalTrials.gov Identifier: NCT00684112     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatrics
Scoliosis
Gabapentin

Additional relevant MeSH terms:
Scoliosis
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Bone Diseases
Membrane Transport Modulators
Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Analgesics
Excitatory Amino Acid Antagonists
Spinal Diseases
Tranquilizing Agents
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Spinal Curvatures
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010