Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

NCT00726999 | Completed Results DMC

• 1 other identifier: 06/71,GC 138
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Postoperative Pain

Keywords

Gabapentin; Pediatric Spinal Fusion; Narcotic Use

Outcome Measures

Primary Outcomes (3)

• 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.

  PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)

• Amount of Morphine Consumed (mg/kg/hr)

  Day 1

• Amount of Morphine Consumed (mg/kg/hr)

  Day 2

Secondary Outcomes (1)

• Number of Ondansetron Doses Administered for Nausea

  First 10 days after surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Gabapentin

Drug: Gabapentin; Drug: Morphine

2

PLACEBO COMPARATOR

Placebo Comparator -- pill matched in appearance to gabapentin

Drug: Placebo; Drug: Morphine

Interventions

Gabapentin DRUG

oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge

Also known as: Neurontin

1

Placebo DRUG

2

Morphine DRUG

Administered as needed

1; 2

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ASA 1-2, Idiopathic Scoliosis

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Lynn Rusy, MD
• Organization: Medical College of Wisconsin

lrusy@chw.org

414-266-2555

Study Officials

• Lynn M Rusy, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: June 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: May 1, 2009
• Last Updated: April 3, 2019
• Results First Posted: December 30, 2010

Record last verified: 2019-03