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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

Page last updated: August 20, 2015

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