Antipyretics for Fever

Overseen By Lina Palomares, RN, LMSW

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Hospital admission, Trauma, Orthopedic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether providing parents with a prescription for the correct dose of acetaminophen and ibuprofen (antipyretics) upon leaving the emergency room can reduce return visits for a child's fever. It involves two groups: one receives a prescription with specific dosing instructions, while the other receives standard instructions without a prescription. The study targets children aged 6 to less than 36 months who have been treated for fever at Dell Children's Medical Center. It is suitable for caregivers who speak English or Spanish and have not previously participated in this study. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance care for children with fevers.

Do I need to stop my child's current medications for the trial?

The trial information does not specify whether your child needs to stop taking their current medications. It focuses on providing acetaminophen and ibuprofen for fever, so it's best to discuss with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that acetaminophen and ibuprofen are generally safe when administered in the correct amounts. These medicines often reduce fever and relieve pain in children.

For acetaminophen, studies indicate it is safe when dosed according to a child's weight. However, excessive intake can cause serious liver damage, so it is crucial not to exceed 4,000 milligrams in one day.

Ibuprofen is also safe when given in the correct dose based on weight. It is available in liquid form or as chewable tablets. As with any medicine, following the dosing instructions is important to avoid side effects.

Both treatments are widely used and have a strong safety record when used properly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a more personalized approach to treating fevers. Unlike the standard care, which usually involves over-the-counter dosing instructions, this trial examines the potential benefits of prescription-based, weight-adjusted dosing for antipyretics like acetaminophen and ibuprofen. By tailoring the dosage to individual needs, there is hope to enhance effectiveness and safety, potentially offering a more precise and effective way to manage fever.

What evidence suggests that this trial's treatments could be effective for reducing unscheduled return visits for fever?

This trial will compare two approaches to antipyretic administration for fever. One group will receive a prescription for weight-based dosing of acetaminophen (Tylenol) and ibuprofen (Motrin), while the other group will receive standard discharge instructions without a prescription. Studies have shown that weight-based dosing of acetaminophen and ibuprofen effectively reduces fever. Specifically, acetaminophen, when dosed by weight, lowers fever as well as aspirin and can be more effective than a fixed dose. Ibuprofen, also given by weight, often reduces fever more effectively than acetaminophen alone in young children. Research suggests that alternating between acetaminophen and ibuprofen controls fever better than using just one. Both medications are generally safe and effective when dosed correctly based on weight. ^{6 7 8 9 10}

Who Is on the Research Team?

Matthew Wilkinson, MD, MPH

Principal Investigator

The University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for children who visit the pediatric emergency department with a fever. The study focuses on whether giving parents a prescription for the right dose of fever-reducing medicine, like acetaminophen or ibuprofen, affects if they come back unexpectedly within a week.

Inclusion Criteria

My caregiver speaks English or Spanish fluently.

My child is between 6 to 36 months old and was evaluated for fever at Dell Children's Medical Center.

Exclusion Criteria

Parent and patient unlikely to follow up in the region (i.e., lives out of state)

I have a bone or joint problem.

I take acetaminophen or ibuprofen for reasons other than fever.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

During ED visit

1 visit (in-person)

Randomization and Discharge

Participants are randomized into intervention or control groups and receive discharge instructions

During ED visit

1 visit (in-person)

Follow-up

Participants are contacted to determine if an unscheduled return visit was made and to assess parental satisfaction

1 week

1 contact (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Prescription Antipyretics

Trial Overview The intervention being tested is providing parents with standard discharge instructions along with a prescription that specifies how much fever-reducing medication their child should take based on weight. This approach will be compared to just giving standard instructions without a prescription.

How Is the Trial Designed?

Group I: Prescription for weight-based dosing of antipyretic Experimental Treatment 1 Intervention

The intervention group (n=220) will receive prescription with weight-based dosing for acetaminophen (also known and prescribed as Tylenol) and ibuprofen (also known and prescribed as Motrin).

Group II: Standard discharge instructions Active Control 1 Intervention

The control group (n=220) will also receive standardized printed discharge instructions, which includes the appropriate dose of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin) but no prescription.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5341528/

Comparison of the Efficacy and Safety of 2 Acetaminophen ... A single dose of acetaminophen 20 to 30 mg/kg produced a greater effect on temperature decrement and duration of antipyretic effect over 8 hours than a single ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291813003500

Dosing and Antipyretic Efficacy of Oral Acetaminophen in ... Those studies demonstrated that acetaminophen produced fever reduction comparable to that of aspirin when dosed on an equivalent dose-by-weight (mg/kg) basis.

3. publications.aap.org publications.aap.org/aapgrandrounds/article/53/1/6/200515/Which-Antipyretic-Therapy-Works-Best-for-Pediatric

Which Antipyretic Therapy Works Best for Pediatric Fever? Acetaminophen alone is less effective than combined therapy with ibuprofen, alternate dosing with ibuprofen, or ibuprofen alone in treating febrile children.

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/204526

Antipyretic Treatment in Young Children With Fever The mean fever of infants in group C (alternating ibuprofen and acetaminophen) was lower as the days progressed as compared with the others groups, with ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482369/

Acetaminophen - StatPearls - NCBI Bookshelf - NIH Adults and adolescents (13 or older) with a body weight <50 kg: The recommended dosage of acetaminophen is 12.5 mg/kg every 4 hours or 15 mg/kg ...

6. tylenol.com tylenol.com/safety-dosing/dosage-for-children-infants

Dosing Chart for Children & Infants TYLENOL® For TYLENOL® Regular Strength Tablets, repeat dose every 4-6 hours while symptoms last. Do NOT give more than 5 doses in 24 hours.

7. healthychildren.org healthychildren.org/English/safety-prevention/at-home/medication-safety/Pages/Acetaminophen-for-Fever-and-Pain.aspx

Acetaminophen Dosing Tables for Fever and Pain in ... Use your child's weight to decide on the right amount to give. If you do not know your child's weight, use your child's age.

8. mayoclinic.org mayoclinic.org/drugs-supplements/acetaminophen-oral-route-rectal-route/description/drg-20068480

Acetaminophen (oral route, rectal route) - Side effects & ... Adults and teenagers—650 to 1000 milligrams (mg) every 4 to 6 hours as needed. Dose is based on form and strength. Carefully follow the label instructions for ...

9. drugs.com drugs.com/dosage/acetaminophen.html

Acetaminophen Dosage Guide + Max Dose, Adjustments Weight-based dosing: 12.5 mg/kg IV every 4 hours OR 15 mg/kg IV every 6 hours · Maximum Single Dose: 15 mg/kg; not to exceed 750 mg · Minimum ...

10. tylenol.com tylenol.com/safety-dosing/what-is-acetaminophen

Acetaminophen Explained: Uses, Dosage & Safety Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours, with other drugs containing acetaminophen, and/or 3 or more alcoholic ...