Recruiting

Oral vs. IV Acetaminophen

Sponsor:

Dr. Niina Kleiber

Code:

NCT05557344

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Acetaminophen IV

Acetaminophen

Study Details

Brief 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.

Conditions

Pain

Study ID

NCT05557344

Start date

Apr 21, 2021

Status verified date

Sep, 2022

Completion date

Mar 1, 2024

Anticipated

Primary completion date

Sep 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Oral acetaminophen arm

they will receive oral acetaminophen, placebo (saline) IV

active comparator: IV acetaminophen arm

they will receive IV acetaminophen, placebo oral

Interventions

Acetaminophen IV

An IV infusion of 15mg/kg of acetaminophen (PrACETAMINOPHEN INJECTION, AVIR Pharma Inc.) (maximum single dose:1g) will be administered regularly every 6h as a 15-minute intravenous infusion. At the same time, an oral placebo with similar appearance as the corresponding acetaminophen oral solution will be administered.

Acetaminophen

A liquid oral acetaminophen suspension will be administered regularly every 6h at a dose of 15mg/kg (maximum single dose: 1g). An IV infusion of NaCl 0.9% corresponding to the volume of IV acetaminophen will be administered as a 15-minute intravenous infusion at the same time as the oral dose. PrACETAMINOPHEN INJECTION ® is a clear and colorless liquid undistinguishable from NaCl 0.9%.

Primary outcome measure

  • Change in pain scores [ Time Frame: During 24h (starting with the first dose of study drug) ]
  • Difference in quantity of rescue opioids [ Time Frame: During 24h (starting with the first dose of study drug) ]

Central Contacts and Locations

Central contacts

Niina Kleiber, MD

(514) 3454931niina.kleiber.med@ssss.gouv.qc.ca

Evelyne Trottier

(514) 3454931evelyne.doyon-trottier.med@ssss.gouv.qc.ca

Locations

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada

Contacts

Niina kleiber, MD

514 3454931niina.kleiber.med@ssss.gouv.qc.ca

More Information

Sponsor

Dr. Niina Kleiber

Last update posted

Sep 28, 2022

Last verified

Sep, 2022

Keywords

  • pain
  • analgesics
  • pediatrics
  • acetaminophen
  • orthopedics
  • pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Niina Kleiber on 2022-09-28.