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Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

Primary Purpose

Scoliosis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring pediatrics, Scoliosis, Gabapentin

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gabapentin

Placebo Control

Arm Description

Single dose preoperative gabapentin

Single dose preoperative placebo control

Outcomes

Primary Outcome Measures

Total morphine consumption postoperatively.

Secondary Outcome Measures

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.

Full Information

First Posted
May 22, 2008
Last Updated
September 15, 2018
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00684112
Brief Title
Analgesic Effects of Gabapentin After Scoliosis Surgery in Children
Official Title
Analgesic Effects of Gabapentin After Scoliosis Surgery in Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
pediatrics, Scoliosis, Gabapentin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
Single dose preoperative gabapentin
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Single dose preoperative placebo control
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Patients in this arm of the study will receive two identical capsules, containing 300 mg of oral gabapentin each, 1 hour before surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.
Primary Outcome Measure Information:
Title
Total morphine consumption postoperatively.
Time Frame
0 to 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Time to first rescue analgesia.
Time Frame
Determined by outcome
Title
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.
Title
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.
Title
Time to first postoperative oral intake as a measure of bowel function.
Time Frame
Determined by outcome

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie Peliowski, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

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