Oral vs IV Acetaminophen for Long-bone Fracture in Children

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Niina Kleiber
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Likely to undergo surgery for a long-bone fracture

• Aged between 2-18 years (IV acetaminophen is approved for children ≥2 years)

• IV line per standard of care

Exclusion Criteria:

• Contraindication to oral drug administration

• Patients unable to take oral solution

• Known hypersensitivity or allergy to acetaminophen or any of the excipients in the IV or oral formulation

• Use of any medication known to interact with acetaminophen including, but not restricted to phenytoin and carbamazepine (1)

• Pregnancy

• Known Hepatic insufficiency or hepatic disease

• Known or diagnosed severe renal failure

• Multiple trauma (more than two long bone fractures)

• Hemodynamic or respiratory compromise

• Altered level of consciousness (Glasgow coma scale <15)