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NCT01977937 · ClinicalTrials.gov registry record · Phase 4
Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin
A Phase 4 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 4
- Development phase
- 55
- Enrollment target
NCT01977937: Completed Phase 4 study, sponsored by Oregon Health and Science University.
NCT01977937 is a Phase 4 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 55 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01977937, a Phase 4 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 55 participants
- Enrollment target
Study 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.
Primary Outcome
Patients will rate their pain using the Visual Analog Pain Scale (VAS). The VAS is a 10 cm line with anchors of "no pain" and "worst pain imaginable." Patients rate their pain by marking on the 10 cm line where they feel their pain is at the time. The mark is then measured according to where it is along the 10 cm line and reported (range is 0.0 at the "no pain end on the left up to 10.0 at the "worst pain imaginable" on the right). Lower pain scores on the VAS scale are considered a better outco
Interventions
- DRUG Simple Syrup
- DRUG Gabapentin 250mg/5mL NDC:59762-5025-01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2013-11 |
| Est. Completion | 2018-04 |
| Phase | Phase 4 |
What the finished NCT01977937 record still lists
NCT01977937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Simple Syrup is the first listed.
NCT01977937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01977937 about?
NCT01977937 is a clinical study titled "Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin". 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 receiv...
What is the current status of trial NCT01977937?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2013-11. Estimated completion is 2018-04.
What interventions are being tested in trial NCT01977937?
The interventions under investigation include: Simple Syrup (DRUG), Gabapentin 250mg/5mL NDC:59762-5025-01 (DRUG).
Who is sponsoring clinical trial NCT01977937?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01977937's enrollment target sits among peer trials
55 1218th of 2000 higher than 778 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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