Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin
Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Gabapentin (Drug); Simple Syrup (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Oregon Health and Science University Overall contact: Matthew Halsey, MD, Phone: 4034946406, Email: halseyma@ohsu.edu
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, satisfaction and narcotic use after discharge
from the hospital 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 opiate medication required for pain
control in pediatric post-operative posterior spinal fusion patients.
Clinical Details
Official title: Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin on Post-operative Opioid Use and Patient Satisfaction
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Difference in pain control when adding gabapentin to a multimodal pain management protocol in pediatric post-operative posterior spinal fusion patients.
Secondary outcome: Determine if opiate usage is less in the gabapentin group versus control.
Eligibility
Minimum age: 10 Years.
Maximum age: 19 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients of age 10-19 with an American Society of Anesthesiologists patient
classification of I to III undergoing surgery to correct idiopathic or neurogenic
scoliosis.
Exclusion Criteria:
- Patients who require a surgical approach or technique differing from posterior spinal
fusion and/or have allergies to any of the standardized or experimental study
medications: acetaminophen, gabapentin, hydromorphone, ketorolac or oxycodone.
Locations and Contacts
Matthew Halsey, MD, Phone: 4034946406, Email: halseyma@ohsu.edu
Oregon Health and Science University, Portland, Oregon 97239, United States; Recruiting Elizabeth B Pedigo, MD, Phone: 503-494-8211, Email: pedigo@ohsu.edu Matthew Halsey, MD, Principal Investigator
Additional Information
Starting date: November 2013
Last updated: April 20, 2015
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