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

NCT ID: NCT07074912

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2026-03-15

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.

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.

Conditions

Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Prescription for weight-based dosing of antipyretic

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Standard discharge instructions

Intervention Type: 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).

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).

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Lina Palomares

Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Wilkinson, MD, MPH

Role: STUDY_DIRECTOR

The University of Texas at Austin

Locations

Dell Children's Medical Center

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lina Palomares, RN, LMSW

Role: CONTACT

lina.palomares@austin.utexas.edu

512-660-7792

Facility Contacts

Medical Director, MD

Role: primary

winniewhitaker@ascension.org

512-324-0000

References

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.

Reference Type: BACKGROUND

PMID: 21357332 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38255334 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00006258

Identifier Type: -

Identifier Source: org_study_id