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 Unknown 300 mg Oral
Background Ibuprofen Small molecule — Oral
Background Ketorolac Tromethamine Small molecule 30 mg Other
Background Ropivacaine Other / unclassified — Other