Prescription Antipyretics to Decrease Unscheduled Return Visits In A Pediatric Emergency Department

NCT07074912 | Recruiting

• 1 other identifier: 00006258
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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

Keywords

emergency department; fever; pediatrics

Outcome Measures

Primary Outcomes (1)

• Unscheduled return visits

  The primary outcome will be unscheduled revisits to the emergency department or urgent care (binary endpoint, i.e., yes/no). This information will be obtained directly from the caregiver/parent of the child. One week (7 days) after the initial visit to the emergency department, research personnel will call the parent/caregiver to ask about length of symptoms and any unscheduled return visits to the emergency department or urgent care for the same symptoms. Any return visits to an emergency department or urgent care will be noted as yes. Well child visits will not be counted.

  7 days

Secondary Outcomes (1)

• Parental satisfaction

  7 days

Study Arms (2)

Prescription for weight-based dosing of antipyretic

EXPERIMENTAL

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).

Other: Prescription for weight-based dosing of antipyretic

Standard discharge instructions

ACTIVE COMPARATOR

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.

Other: Standard discharge instructions

Interventions

Prescription for weight-based dosing of antipyretic OTHER

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).

Prescription for weight-based dosing of antipyretic

Standard discharge instructions OTHER

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).

Standard discharge instructions

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Children's Medical Center

Austin, Texas, 78723, United States

RECRUITING

Related Publications (2)

• Section on Clinical Pharmacology and Therapeutics; Committee on Drugs; Sullivan JE, Farrar HC. Fever and antipyretic use in children. Pediatrics. 2011 Mar;127(3):580-7. doi: 10.1542/peds.2010-3852. Epub 2011 Feb 28.

  PMID: 21357332 BACKGROUND

• Trapani S, Fiordelisi A, Stinco M, Resti M. Update on Fever of Unknown Origin in Children: Focus on Etiologies and Clinical Approach. Children (Basel). 2023 Dec 24;11(1):20. doi: 10.3390/children11010020.

  PMID: 38255334 BACKGROUND

MeSH Terms

Conditions

Fever; Emergencies

Interventions

Prescriptions

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Matthew Wilkinson, MD, MPH

  The University of Texas at Austin

  STUDY DIRECTOR

Central Study Contacts

Lina Palomares, RN, LMSW

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 20, 2025
• Study Start: December 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 15, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)