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Completed

NCT Number: NCT00726999

Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

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).

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Key information

Conditions

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

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1-2, Idiopathic Scoliosis

Exclusion criteria

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

Treatment and study plan

Gabapentin

Drug

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

Other names: Neurontin

Placebo

Drug

Morphine

Drug

Administered as needed

Primary outcomes

  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 outcomes

  1. Number of Ondansetron Doses Administered for Nausea

    Time frame: First 10 days after surgery

    The number of doses of Ondansetron given for nausea to participants in both groups.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Children's Hospital and Health System Foundation, Wisconsin

Registry information

Official study title

Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Aug 1, 2008
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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