Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arie Peliowski, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00684112
First received: May 22, 2008
Last updated: August 15, 2013
Last verified: August 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 ]

Enrollment: 35
Study Start Date: May 2008
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin
Single dose preoperative gabapentin
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 Comparator: Placebo Control
Single dose preoperative placebo control
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684112

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
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: Arie Peliowski, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00684112     History of Changes
Other Study ID Numbers: 1000010379
Study First Received: May 22, 2008
Last Updated: August 15, 2013
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on July 09, 2014