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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 belowSelect...
I am likely to have surgery for a broken major bone.
Select...
I am between 2 and 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during 24 hours after the first dose of study drug
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 24 hours after the first dose of study drug
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
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Who is running the clinical trial?
Dr. Niina KleiberLead Sponsor
Niina Kleiber, MD PhDPrincipal InvestigatorSt. Justine's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am likely to have surgery for a broken major bone.I have liver problems.You are pregnant.I am between 2 and 18 years old.I am not taking medications like phenytoin or carbamazepine.I have been diagnosed with severe kidney failure.I cannot take medications by mouth.I have an IV line as part of my usual treatment.You are allergic to acetaminophen or any ingredients in the IV or oral medication.I cannot take medicine by mouth.I do not have severe heart or lung problems.I have had multiple long bone fractures.My consciousness level is reduced (not fully alert).
Research Study Groups:
This trial has the following groups:- Group 1: IV acetaminophen arm
- Group 2: Oral acetaminophen arm
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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