drugset / Trial / NCT06935331

Prospective Opioid-Free AIS Fusion

NCT06935331

Phase 4 Enrolling by invitation 58 enrolled OrthoCarolina Research Institute, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy of a multimodal opioid-free (OF) pain management protocol with a traditional opioid-containing (OC) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis.

Timeline

Start
2025-10-14
Primary completion
2026-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule Oral
Comparator Hydrocodone Unknown Oral
Comparator Morphine Other / unclassified Intravenous
Comparator Acetaminophen Small molecule Oral
Background Clonidine Other / unclassified Other
Background Diazepam Small molecule Oral
Background Epinephrine Other / unclassified Other
Background Gabapentin Small molecule 300 mg Oral
Background Ibuprofen Small molecule Oral
Background Ketorolac Tromethamine Small molecule 30 mg Other
Background Ropivacaine Other / unclassified Other