Oral vs IV Acetaminophen for Long-bone Fracture in Children
Oral Versus Intravenous Acetaminophen for the Treatment of Pain Secondary to Long Bone Fracture Requiring Surgery in Children
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 pain
Started Apr 2021
Longer than P75 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2021
CompletedFirst Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
September 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedSeptember 28, 2022
September 1, 2022
2.4 years
August 24, 2022
September 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in pain scores
Pain scores within the first 24 hours following initiation of study drug, using the scales Face, Legs, Activity, Cry, Consolability (FLACC, 0-2 per item for a total of 10, 10 being the worst pain) and verbal numerical rating (VNR, 0-10, 10 being the worst pain).
During 24h (starting with the first dose of study drug)
Difference in quantity of rescue opioids
Quantity of rescue opioids (morphine equivalent in mg/kg) within the first 24 hours following initiation of study drug
During 24h (starting with the first dose of study drug)
Secondary Outcomes (2)
Adverse events
During 24h (starting with the first dose of study drug)
Determination of oral bioavailability
During 24 hours after the first dose of study drug
Study Arms (2)
Oral acetaminophen arm
ACTIVE COMPARATORthey will receive oral acetaminophen, placebo (saline) IV
IV acetaminophen arm
ACTIVE COMPARATORthey will receive IV acetaminophen, placebo oral
Interventions
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.
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%.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Sainte-Justine
Montreal, Quebec, Canada
Related Publications (1)
Ulrich M, Chamberland M, Bertoldi C, Garcia-Bournissen F, Kleiber N. Newly approved IV acetaminophen in Canada: Switching from oral to IV acetaminophen. Is IV worth the price difference? A systematic review. Paediatr Child Health. 2021 Mar 13;26(6):337-343. doi: 10.1093/pch/pxaa137. eCollection 2021 Oct.
PMID: 34676011BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niina Kleiber, MD PhD
St. Justine's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Paediatrician and Clinical Pharmacologist
Study Record Dates
First Submitted
August 24, 2022
First Posted
September 28, 2022
Study Start
April 21, 2021
Primary Completion
September 1, 2023
Study Completion
March 1, 2024
Last Updated
September 28, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share