Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin
Completed · Phase 4
Conditions studied: Pain, Postoperative
In brief
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.
Key facts
- Study ID
- NCT01977937
- Run by
- Oregon Health and Science University
- People needed
- 55
- Starts
- 2013-11-01
- Expected to finish
- 2018-04-01
- Last updated by the study team
- 2019-06-12
Who can join
Age: 10 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Oregon Health and Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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