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

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.

Study Overview

• Status: Recruiting
• Conditions: Fever
• Intervention / Treatment: Other: Prescription for weight-based dosing of antipyretic; Other: Standard discharge instructions

Detailed Description

Unscheduled return visits (URV) to the Emergency Department (ED) are a burden on both the healthcare system and patients. Published literature has attempted to categorize the rate of URV and type of complaints that lead to URVs. Rate of URV is variable, but as high as 22% for children with infectious illnesses and parents often return to the ED due to unresolved fever in a child. Unresolved fever may be due to continued progressive worsening of illness or inability to provide the appropriate amount of anti-pyretic (anti fever) medicine to the child, as pediatric medication dosing is not only age-based, but also weight-based. This increased variability could lead to confusion on the part of the caregivers. There are no published studies looking at whether appropriately prescribed antipyretics decrease the rate of return visits. Further, there is no standardization for antipyretic prescribing nationally or at the research team's hospital and some providers frequently provide prescriptions for these medications while others almost never do. It is unknown if providing a prescription for an over-the-counter medication makes a difference with health outcomes. The study aims to evaluate whether unscheduled return visits within one week for similar complaints are impacted by ensuring parents leave the ED with a prescription for appropriately dosed acetaminophen and ibuprofen.

This study will be a single center, randomized controlled trial in the pediatric emergency department (ED) at the north or central campus of Dell Children's Medical Center (DCMC). Patients meeting inclusion and exclusion criteria will be identified by research personnel during the ED visit.

Patients will be randomized to the intervention or control group after parental/caregiver permission is obtained for general participation in a research study. Computerized randomization functions and opaque envelopes will be used to achieve random assignment and allocation concealment. Patient care will look the same for all participants, but discharge process will differ slightly for each group. Both groups will receive standard discharge education, but the intervention group (n=220) will receive prescription with weight-based dosing for acetaminophen and ibuprofen. The control group (n=220) will also receive standardized printed discharge instructions, which includes the appropriate dose of acetaminophen and ibuprofen. As noted above, there is no standardization for antipyretic prescribing nationally or at our hospital. Some providers frequently provide prescriptions for these medications while others almost never do. It is unknown if providing a prescription for an over-the-counter medication makes a difference with patient satisfaction or health outcomes justifying the additional costs to the healthcare system.

One week after discharge, research personnel will contact participants to determine if an unscheduled return visit was made, and, if so, the reason why. Research personnel will ask about visits to EDs, urgent cares, and clinics/primary care providers, and about participant satisfaction with the care they received in the ED. The primary outcome will be unscheduled revisits to the ED (binary endpoint). Secondary endpoints include total number of unscheduled return visits, return with hospital admission, and parental satisfaction with ED care. The participant/caregiver will be debriefed on the randomization part of the study at this time and permission will be requested for continued use their child's health data and the caregiver's responses for the purposes of the research study.

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lina Palomares, RN, LMSW; Phone Number: 512-660-7792; Email: lina.palomares@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78723
      • Recruiting
      • Dell Children's Medical Center
      • Contact: Medical Director, MD; Phone Number: 512-324-0000; Email: winniewhitaker@ascension.org
      • Principal Investigator: Bradley Yingst, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Other: 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).
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.	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental satisfaction	Parental satisfaction with care received in the emergency department. Parents/caregivers will be contacted one week (7 days) after the initial visit to the emergency department and asked about their satisfaction with the visit ("How satisfied were you with the care your child received at the Dell Children's Medical Center Emergency Department?"). Responses are captured on a Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied) and parents/caregivers will be given an opportunity to expand on the level of satisfaction.	7 days

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Study Director: Matthew Wilkinson, MD, MPH, The University of Texas at Austin

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: July 1, 2025
• First Submitted That Met QC Criteria: July 10, 2025
• First Posted (Actual): July 20, 2025

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: pediatrics; fever; emergency department
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Antipyretics
• Other Study ID Numbers: 00006258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IDP will not be shared to protect patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No