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Analgesic

Oral vs IV Acetaminophen for Broken Bones in Children

Phase 4
Recruiting
Led By Niina Kleiber, MD PhD
Research Sponsored by Dr. Niina Kleiber
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Likely to undergo surgery for a long-bone fracture
Aged between 2-18 years (IV acetaminophen is approved for children ≥2 years)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 24 hours after the first dose of study drug
Awards & highlights

Study Summary

This trial will help to determine if IV acetaminophen is more effective than oral acetaminophen in reducing pain for children with long-bone fractures.

Who is the study for?
This trial is for children aged 2-18 who are likely to have surgery for a long-bone fracture and already have an IV line. It's not for pregnant kids, those with liver problems or severe kidney failure, allergies to acetaminophen, on certain meds like phenytoin, or with multiple traumas or altered consciousness.Check my eligibility
What is being tested?
The study compares the effects of IV versus oral acetaminophen in managing pain from long-bone fractures in children. The goal is to see if IV can reduce opioid use by providing better pain relief and what side effects each method might have.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site for IV acetaminophen, digestive issues like nausea or vomiting, skin rashes due to allergy, and rarely liver damage if too much is taken.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am likely to have surgery for a broken major bone.
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I am between 2 and 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 24 hours after the first dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and during 24 hours after the first dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pain scores
Difference in quantity of rescue opioids
Secondary outcome measures
Adverse events
Determination of oral bioavailability

Trial Design

2Treatment groups
Active Control
Group I: IV acetaminophen armActive Control1 Intervention
they will receive IV acetaminophen, placebo oral
Group II: Oral acetaminophen armActive Control1 Intervention
they will receive oral acetaminophen, placebo (saline) IV

Find a Location

Who is running the clinical trial?

Dr. Niina KleiberLead Sponsor
Niina Kleiber, MD PhDPrincipal InvestigatorSt. Justine's Hospital

Media Library

Acetaminophen (Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05557344 — Phase 4
Pain Research Study Groups: IV acetaminophen arm, Oral acetaminophen arm
Pain Clinical Trial 2023: Acetaminophen Highlights & Side Effects. Trial Name: NCT05557344 — Phase 4
Acetaminophen (Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557344 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this medical experiment open to me?

"Up to 20 eligible candidates in the 2-18 age bracket might join this research, given they meet specific criteria. These include a predisposition for surgery due to a long bone fracture, as well as having access to an intravenous line per usual medical practice and being of legal age (2 or over) for taking IV acetaminophen."

Answered by AI

Is enrollment for this experiment still in progress?

"Affirmative. According to the information presented on clinicaltrials.gov, this clinical research is recruiting participants as of now. This trial was first published April 21st 2021 and has been updated September 23rd 2022. The study aims to enrol 20 individuals across a single site."

Answered by AI

How many individuals have been recruited for participation in this experiment?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this research, which was initiated on April 21st 2021, is actively recruiting patients. The investigators need to recruit 20 participants from a single medical centre."

Answered by AI

Are the age restrictions for this medical experiment limited to those aged 30 and above?

"Eligibility for this medical trial is limited to those between the ages of 2 and 18. According to available research, there are 135 studies pertaining to participants under the age of 18 and 529 involving seniors aged 65 or older."

Answered by AI

What potential adverse effects could patients experience when taking the Oral acetaminophen arm?

"With Phase 4 trials indicating the approval of this medication, our analysts at Power have assigned a safety score of 3 to Oral acetaminophen."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Oral vs IV Acetaminophen for Long-bone Fracture in Children
Dr. Niina Kleiber 2021. "Oral vs IV Acetaminophen for Long-bone Fracture in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05557344.
~5 spots leftby Apr 2025
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