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Analgesic

Tylenol Dosing for Childhood Obesity

Phase 3
Recruiting
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant will be a Children's National Health System (CNHS) inpatient or outpatient admitted for at least 24 hours observation as part of the surgical plan of care
Age range will be between 10 and 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will study how well acetaminophen works in obese children and adolescents.

Who is the study for?
This trial is for obese children and adolescents aged 10-18 who are patients at Children's National Health System. They must be observed as part of a surgical plan for at least 24 hours, have a BMI in the obese range (equal to or above the 95th percentile), and an ASA classification I, II, or III. It excludes those with liver disease, recent acetaminophen use, allergy to it, pregnancy/lactation, renal insufficiency, certain drug treatments affecting metabolism enzymes CYP2E1/UGT, Gilbert-Meulengracht Syndrome sufferers, recent alcohol intake/smoking or diabetes type II.Check my eligibility
What is being tested?
The study is examining how Tylenol (acetaminophen) works in the bodies of obese young people—how quickly it's processed (pharmacokinetics) and its effects on pain relief and fever reduction (pharmacodynamics). The goal is to understand if dosing should be different compared to kids with normal weight.See study design
What are the potential side effects?
While not specified here since this trial focuses on pharmacokinetics/pharmacodynamics rather than side effects directly; generally Tylenol can cause nausea/vomiting/diarrhea/rash. Overdose risks include liver damage/failure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will be admitted to CNHS for at least 24 hours as part of my surgery plan.
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I am between 10 and 18 years old.
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My overall health is good to moderately impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Systemic clearance of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in adolescent surgical patients
Secondary outcome measures
Evaluate postoperative pain management using the numerical rating scale system.

Side effects data

From 2014 Phase 4 trial • 323 Patients • NCT01587274
6%
Nausea/ vomiting
5%
Stomach irritation
4%
Dizziness
4%
Drowsiness
3%
Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naproxen Alone
Opioid
Skeletal Muscle Relaxant

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tylenol DosingExperimental Treatment1 Intervention
Dosing of Tylenol for postoperative pain relief will include: children < 16 years; 650 mg every 6 hours, max 2.6 gram per 24 hours and children > or equal to 16 years every 6 hours 1 g of acetaminophen, max 4 gram per 24 hours).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
FDA approved

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
209 Previous Clinical Trials
207,739 Total Patients Enrolled

Media Library

Acetaminophen (Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT03192566 — Phase 3
Childhood Obesity Research Study Groups: Tylenol Dosing
Childhood Obesity Clinical Trial 2023: Acetaminophen Highlights & Side Effects. Trial Name: NCT03192566 — Phase 3
Acetaminophen (Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03192566 — Phase 3

Frequently Asked Questions

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

How many people are allowed to be a part of this clinical research project at one time?

"That is correct. The information available from clinicaltrials.gov reveals that this study, which was first advertised on August 1st 2016, is still admitting patients. So far, 6 individuals have been recruited from a single site."

Answered by AI

Are there any current openings for participants in this trial?

"That is accurate. The information available on clinicaltrials.gov suggests that the trial administrators are still looking for participants. This study was first posted on 8/1/2016, with the most recent update being made on 4/7/2021. They need 6 patients total, but only have 1 site so far."

Answered by AI

How do I sign up for this opportunity to test a new medication?

"Up to 6 obese patients between the ages of 10 and 18 will be admitted into this trial. Most notably, candidates are required to meet the following criteria: they must be a Children's National Health System (CNHS) inpatient or outpatient admitted for at least 24 hours observation as part of the surgical plan of care, their BMI% will need to calculated using height and weight and fall within the 5th-85th% (normal weight) or greater than or equal to 95th %.( obese weight), Lastly, all racial and ethnic groups will be included."

Answered by AI

Can people below the age of 40 years old participate in this research project?

"The target age range for this clinical trial are patients that are between 10 to 18 years old."

Answered by AI

Has Tylenol been cleared by the FDA?

"Tylenol is considered to be safe because it has completed Phase 3 clinical trials."

Answered by AI

What ailments does Tylenol commonly address?

"Tylenol is often used to ameliorate the symptoms of catarrh, but it can also be helpful for patients experiencing rhinorrhoea, musculoskeletal pain, and muscle spasms."

Answered by AI

Could you please direct me to other research that has looked at Tylenol?

"There are currently 98 ongoing clinical trials evaluating Tylenol's efficacy. Out of these, 29 studies have progressed to Phase 3. While a few investigations into Tylenol are happening in Pittsburgh, 1008 different medical facilities across the globe are running similar experiments."

Answered by AI
~0 spots leftby Aug 2024