Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00726999
Recruitment Status : Completed
First Posted : August 1, 2008
Results First Posted : December 30, 2010
Last Update Posted : January 4, 2011
Children's Hospital and Health System Foundation, Wisconsin
Information provided by:
Medical College of Wisconsin

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).

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Gabapentin Drug: Placebo Drug: Morphine Not Applicable

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  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients
Study Start Date : June 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
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

Primary Outcome Measures :
  1. Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour) ]
    Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.

  2. Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: Day 1 ]
  3. Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: Day 2 ]

Secondary Outcome Measures :
  1. Side Effect Occurrence [ Time Frame: First 10 days after surgery ]
    The number of episodes of/occurrence of side effects was monitored in both groups.

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ASA 1-2, Idiopathic Scoliosis

Exclusion Criteria:

  • ASA 3 or greater
  • Neuromuscular scoliosis
  • On narcotics baseline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00726999

Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Principal Investigator: Lynn M Rusy, MD Medical College of Wisconsin

Responsible Party: Dr. Lynn M. Rusy, Medical College of Wisconsin Anesthesia Department Identifier: NCT00726999     History of Changes
Other Study ID Numbers: 06/71,GC 138
First Posted: August 1, 2008    Key Record Dates
Results First Posted: December 30, 2010
Last Update Posted: January 4, 2011
Last Verified: January 2011

Keywords provided by Medical College of Wisconsin:
Pediatric Spinal Fusion
Narcotic Use

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
gamma-Aminobutyric Acid
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents