Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gabapentin
Placebo
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Gabapentin, Pediatric Spinal Fusion, Narcotic Use
Eligibility Criteria
Inclusion Criteria:
- ASA 1-2, Idiopathic Scoliosis
Exclusion Criteria:
- ASA 3 or greater
- Neuromuscular scoliosis
- On narcotics baseline
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Gabapentin
Placebo Comparator -- pill matched in appearance to gabapentin
Outcomes
Primary Outcome Measures
Amount of Morphine Consumed (mg/kg/hr)
Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.
Amount of Morphine Consumed (mg/kg/hr)
Amount of Morphine Consumed (mg/kg/hr)
Secondary Outcome Measures
Number of Ondansetron Doses Administered for Nausea
The number of doses of Ondansetron given for nausea to participants in both groups.
Full Information
NCT ID
NCT00726999
First Posted
July 30, 2008
Last Updated
March 21, 2019
Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT00726999
Brief Title
Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion
Official Title
Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (pruritis, days foley, days to first stool, sedation, pain scores, PCA use).
Detailed Description
Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion.
Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, with standard PCA morphine
No remifentanil, clonidine, ketamine
N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Gabapentin, Pediatric Spinal Fusion, Narcotic Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Gabapentin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator -- pill matched in appearance to gabapentin
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Administered as needed
Primary Outcome Measure Information:
Title
Amount of Morphine Consumed (mg/kg/hr)
Description
Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.
Time Frame
PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)
Title
Amount of Morphine Consumed (mg/kg/hr)
Time Frame
Day 1
Title
Amount of Morphine Consumed (mg/kg/hr)
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Number of Ondansetron Doses Administered for Nausea
Description
The number of doses of Ondansetron given for nausea to participants in both groups.
Time Frame
First 10 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA 1-2, Idiopathic Scoliosis
Exclusion Criteria:
ASA 3 or greater
Neuromuscular scoliosis
On narcotics baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn M Rusy, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion
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