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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 is a Phase 4 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 55 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01977937
The ClinicalTrials.gov registry entry for NCT01977937 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Simple Syrup is the first listed.
NCT01977937 reports 0 study locations.
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.
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