Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion - Full Text View

Sponsor:	Medical College of Wisconsin
Collaborator:	Children's Hospital and Health System Foundation, Wisconsin
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00726999

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	Intervention
Postoperative Pain	Drug: Gabapentin Drug: Placebo Drug: Morphine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients

Resource links provided by NLM:

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

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 ]

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.

Enrollment:	63
Study Start Date:	June 2006
Study Completion Date:	May 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Gabapentin	Drug: Gabapentin oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge Other Name: Neurontin Drug: Morphine Administered as needed
Placebo Comparator: 2 Placebo Comparator -- pill matched in appearance to gabapentin	Drug: Placebo Drug: Morphine Administered as needed

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

Eligibility

Ages Eligible for Study:	9 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ASA 1-2, Idiopathic Scoliosis

Exclusion Criteria:

ASA 3 or greater
Neuromuscular scoliosis
On narcotics baseline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726999

Sponsors and Collaborators

Medical College of Wisconsin

Children's Hospital and Health System Foundation, Wisconsin

Investigators

Principal Investigator:

Lynn M Rusy, MD

Medical College of Wisconsin

More Information

No publications provided

Responsible Party:	Dr. Lynn M. Rusy, Medical College of Wisconsin Anesthesia Department
ClinicalTrials.gov Identifier:	NCT00726999 History of Changes
Other Study ID Numbers:	06/71,GC 138
Study First Received:	July 30, 2008
Results First Received:	August 19, 2010
Last Updated:	January 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical College of Wisconsin:

Gabapentin
Pediatric Spinal Fusion
Narcotic Use

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Narcotics
Gabapentin
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Central Nervous System Depressants
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012