drugset / Trial / NCT05557344

Oral vs IV Acetaminophen for Long-bone Fracture in Children

NCT05557344 ↗

Phase 4 Unknown 20 enrolled Dr. Niina Kleiber
RandomizedParallel-groupSingle-blindSupportive care

Summary

Intravenous (IV) acetaminophen entered the Canadian market recently and children with acute pain following a trauma are ideal candidates for the IV formulation as it may improve analgesia and consequently decrease the amount of opioids needed to achieve pain control. Due to the limited data on bioavailability, adverse effect profile and efficacy of IV versus oral acetaminophen, it is of paramount importance to generate evidence-based data to guide clinicians with a rational choice of route of administration of acetaminophen. Therefore, we propose a pilot study to inform a future large randomized controlled trial (RCT) to compare pharmacokinetics, feasibility, preliminary effects and side effects profile of oral versus IV acetaminophen in children admitted for surgical fixation of a long-bone fracture.

Timeline

Start
2021-04-21
Primary completion
2023-09-01
Completion
2024-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 15 mg/kg Intravenous

Indications

No indication recorded.