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Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin

NCT01977937 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2019-06-12

Study results available
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Summary

The purpose of this study is to evaluate the patient experience when using gabapentin with other pain control medications after posterior spinal fusion surgery for scoliosis in adolescents. These results will be compared to patients who underwent the same procedure during the study period and received the same standardized pain control regimen excluding gabapentin. Effects on pain level, opioid use, and satisfaction will be measured. Opioid side effects including nausea, sedation and urinary retention (inability to empty one's bladder) will also be recorded.The null hypotheses are as follows:

1. There is no significant difference in pain control when adding gabapentin to a multimodal pain management protocol in pediatric post-operative posterior spinal fusion patients.
2. There is no significant difference in the amount of opioid medication required for pain control in pediatric post-operative posterior spinal fusion patients.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Gabapentin 250mg/5mL NDC:59762-5025-01

DRUG

Simple Syrup

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Matthew Halsey, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01977937 on ClinicalTrials.gov