CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 55 enrolled
Drug / intervention
Gabapentin 250mg/5mL NDC:59762-5025-01 +1 moredrug
Likely dose
Gabapentin 250mg/5mL NDC:59762-5025-01from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01977937
NCT01977937Phase 4Completed

Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin on Post-operative Opioid Use and Patient Satisfaction

Oregon Health and Science University·interventional·Posted Nov 7, 2013·Updated Jun 12, 2019

In Brief

A Phase 4 clinical trial evaluating Gabapentin 250mg/5mL NDC:59762-5025-01 and Simple Syrup for Pain, Postoperative. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 7, 2013
Enrollment StartNov 1, 2013
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 12.7 years ago

Interventions

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

Simple Syrupdrug