Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion | RxWiki

Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

Overview[ - collapse ][ - ]

Purpose	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).
Condition	Postoperative Pain
Intervention	Drug: Gabapentin Drug: Placebo Drug: Morphine
Phase	N/A
Sponsor	Medical College of Wisconsin
Responsible Party	Medical College of Wisconsin
ClinicalTrials.gov Identifier	NCT00726999
First Received	July 30, 2008
Last Updated	January 3, 2011
Last verified	January 2011

Tracking Information[ + expand ][ + ]

First Received Date	July 30, 2008
Last Updated Date	January 3, 2011
Start Date	June 2006
Estimated Primary Completion Date	May 2009
Current Primary Outcome Measures	Amount of Morphine Consumed (mg/kg/hr) [Time Frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)] [Designated as safety issue: No]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) [Time Frame: Day 1] [Designated as safety issue: No] Amount of Morphine Consumed (mg/kg/hr) [Time Frame: Day 2] [Designated as safety issue: No]
Current Secondary Outcome Measures	Side Effect Occurrence [Time Frame: First 10 days after surgery] [Designated as safety issue: No]The number of episodes of/occurrence of side effects was monitored in both groups.

Descriptive Information[ + expand ][ + ]

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
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
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Postoperative Pain
Intervention	Drug: Gabapentin oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge Other Names: NeurontinDrug: Placebo Drug: Morphine Administered as needed
Study Arm (s)	Active Comparator: 1 Gabapentin Placebo Comparator: 2 Placebo Comparator -- pill matched in appearance to gabapentin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	63
Estimated Completion Date	May 2009
Estimated Primary Completion Date	July 2008
Eligibility Criteria	Inclusion Criteria: - ASA 1-2, Idiopathic Scoliosis Exclusion Criteria: - ASA 3 or greater - Neuromuscular scoliosis - On narcotics baseline
Gender	Both
Ages	9 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00726999
Other Study ID Numbers	06/71,GC 138
Has Data Monitoring Committee	Yes
Information Provided By	Medical College of Wisconsin
Study Sponsor	Medical College of Wisconsin
Collaborators	Children's Hospital and Health System Foundation, Wisconsin
Investigators	Principal Investigator: Lynn M Rusy, MD Medical College of Wisconsin
Verification Date	January 2011