Recruiting

Acetaminophen & Ibuprofen

Sponsor:

University of Texas at Austin

Code:

NCT07074912

Conditions

Fever

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

Prescription for weight-based dosing of antipyretic

Standard discharge instructions

Study Details

Brief summary:

The study aims to evaluate whether unscheduled return visits within one week for similar complaints are impacted by ensuring parents leave the emergency department (ED) with a prescription for appropriately dosed acetaminophen and ibuprofen for their child.

Conditions

Fever

Study ID

NCT07074912

Start date

Dec 15, 2024

Status verified date

Jul, 2025

Completion date

Mar 15, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children 6 to < 36 months of age being discharged home from Dell Children's Medical Center emergency department who are evaluated for fever
  • Caregiver fluent in English or Spanish

Exclusion Criteria:

  • Previous enrollment in this study
  • Patient admitted to hospital
  • Parental request for a prescription for acetaminophen and/or ibuprofen
  • Trauma patient
  • Orthopedic complaint
  • Other painful indication for acetaminophen or ibuprofen
  • Acetaminophen or ibuprofen prescribed for anything other than fever
  • Allergy or another contraindication to acetaminophen or ibuprofen
  • Parent and patient unlikely to follow up in the region (i.e., lives out of state)

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prescription for weight-based dosing of antipyretic

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).

active comparator: Standard discharge instructions

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.

Interventions

Prescription for weight-based dosing of antipyretic

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

Standard discharge instructions

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

Primary outcome measure

  • Unscheduled return visits [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Lina Palomares, RN, LMSW

512-660-7792lina.palomares@austin.utexas.edu

Locations

Dell Children's Medical Center

Recruiting

Austin, Texas, United States, 78723

Contacts

Medical Director, MD

512-324-0000winniewhitaker@ascension.org

Principal Investigator:

Bradley Yingst, DO

More Information

Sponsor

University of Texas at Austin

Last update posted

Jul 20, 2025

Last verified

Jul, 2025

Keywords

  • emergency department
  • fever
  • pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2025-07-20.