FeverNCT07074912
Prescription Antipyretics to Decrease Unscheduled Return Visits In A Pediatric Emergency Department
A study testing Prescription for weight-based dosing of antipyretic and Standard discharge instructions in people with Fever, run by University of Texas at Austin at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Fever
- What is being tested?
- Prescription for weight-based dosing of antipyretic and Standard discharge instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2024to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dell Children's Medical Center
Austin, Texas, 78723
Medical Director, MD, 512-324-0000, winniewhitaker@ascension.org
Bradley Yingst, DO
About this study
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.
- Conditions
- Fever
- Being tested
- Prescription for weight-based dosing of antipyretic, Standard discharge instructions
- Keywords
- emergency department, fever, pediatrics
- Medical subject headings
- Fever, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription for weight-based dosing of antipyreticOther
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 instructionsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Standard discharge instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start15 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lina Palomares, University of Texas at Austin
- Investigators
- Matthew Wilkinson, MD, MPH, Study director, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074912
- Sponsor's protocol ID
- 00006258
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will not be shared to protect patient confidentiality.
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 21357332Trapani 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 at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription Antipyretics to Decrease Unscheduled Return Visits In A Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT07074912
- Acronym / sponsor ID
- 00006258
- Conditions
- Fever
- Keywords
- emergency department, fever, pediatrics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescription for weight-based dosing of antipyretic | Experimental | Other: Prescription for weight-based dosing of antipyreticThe 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). |
| Standard discharge instructions | Active comparator | Other: Standard discharge instructionsThe 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. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- Previous enrollment in this study
- Patient admitted to hospital
- Parental request for a prescription for acetaminophen and/or ibuprofen
- Trauma patient
- Orthopedic complaint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescription for weight-based dosing of antipyreticThe 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). | Other | Prescription for weight-based dosing of antipyretic |
| Standard discharge instructionsThe 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). | Other | Standard discharge instructions |
Primary outcome
Unscheduled return visits
Time frame: 7 days
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.
1 secondary outcome
Parental satisfaction
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Background: PubMed 21357332Section 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.
- Background: PubMed 38255334Trapani 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.
- Individual participant dataSharing planned: No. IDP will not be shared to protect patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Wilkinson, MD, MPH study director
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription for weight-based dosing of antipyretic and Standard discharge instructions in people with Fever, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Palomares, RN, LMSW (512-660-7792, lina.palomares@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unscheduled return visits (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07074912, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.