Phase 4
N=55
Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT01977937 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Difference in Pain Control When Adding Gabapentin to a Multimodal Pain Management Protocol in Pediatric Post-operative Posterior Spinal Fusion Patients. — 2.46; 3.46 pain score on a scale — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gabapentin 250mg/5mL NDC:59762-5025-01 (Drug); Simple Syrup (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Pain Control When Adding Gabapentin to a Multimodal Pain Management Protocol in Pediatric Post-operative Posterior Spinal Fusion Patients. |
2.46; 3.46 | 0.07 |
| SECONDARY Opiate Usage in the Gabapentin Group Versus Control. |
3.58; 5.33 | 0.02 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01977937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.