ClinicalTrials.gg
RecruitingNCT07074912Updated Jul 20, 2025

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

An interventional study of Prescription for weight-based dosing of antipyretic and Standard discharge instructions in Fever, sponsored by University of Texas at Austin. Recruiting at 1 site in United States. Open to participants aged 6 Months to 36 Months. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Dec 2024, registered Jul 2025).
  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
440
Allocation
Randomized
Ages
6 Months to 36 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fever

Keywords

  • emergency department
  • fever
  • pediatrics
03

In context

Fever

438 studies on the registry are indexed under Fever; 55 are open to participants now.

This study's planned enrollment of 440 is above the median of 123 across 271 interventional studies indexed under Fever.

Browse Fever studies →

Lead sponsor

University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 36 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to acetaminophen or ibuprofen
  • Parent and patient unlikely to follow up in the region (i.e., lives out of state)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
440 participants (estimated)

Study 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).

    Other: Prescription for weight-based dosing of antipyretic

  • 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

Interventions

  • OtherPrescription 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).

  • OtherStandard 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).

06

What researchers measure

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.

    Time frame: 7 days

Secondary outcomes

  1. 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.

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 21357332 ↗
  • 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. PubMed 38255334 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — IDP will not be shared to protect patient confidentiality.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Dec 2025, 12 months after the start.

Of 66 non-industry interventional studies with no phase under Fever, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 12 months is below that.

Counting every sponsor, half of 74 studies reached it within 16 months; a quarter within 6 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2025
First posted
Jul 20, 2025
StartActual
Dec 15, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Mar 15, 2026
Last update
Jul 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07074912
Responsible party
Lina Palomares (Project Manager, University of Texas at Austin) — Principal investigator
First posted
Jul 20, 2025
Start date
Dec 15, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Mar 15, 2026 (estimated)
Last update
Jul 20, 2025

Study contacts

Lina Palomares, RN, LMSW
Contact
lina.palomares@austin.utexas.edu
512-660-7792
Matthew Wilkinson, MD, MPH
study director · The University of Texas at Austin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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