FeverNCT05366049
The Effect of Methods Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever
A study testing using a medicine pacifier to give acetaminophen in people with Fever and Heart Rate, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Fever, one of the most common clinical journeys of childhood, makes up a fraction of emergency room admissions. About us-30. High fever, which is one of the first schools in infancy and childhood, can cause health problems such as not applying or starting the intervention. Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Fever, Heart Rate, Respiratory Rate
- What is being tested?
- using a medicine pacifier to give acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Applying to the pediatric emergency department with a complaint of high fever (38ºC).
- Being prescribed an antipyretic (paracetamol) by a physician.
- Those whose parents are literate and agree to participate in the study.
- Patients with triage color classification Yellow and Green.
- Children between 0-24 months will be included in the study.
Who cannot join
- Having used antipyretics in the last 6 hours.
- Being prescribed an antipyretic other than paracetamol by the physician.
- Having trouble in sucking-swallowing coordination.
- Children with chronic disease and neuromotor developmental delay.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Unisversity- Cerrahpasa
Istanbul, Fatih, 34320
About this study
Official title: The Effect of Injector and Pacifier Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever
Fever, one of the most common clinical journeys of childhood, makes up a fraction of emergency room admissions. About us-30. High fever, which is one of the first schools in infancy and childhood, can cause health problems such as not applying or starting the intervention. The most preferred method in the fire; antipyretic drug treatment in the hospital is routine . Antipyretics play a role in control plans and estimations of facts for cars of cars, the importance of word of mouth has some problems. In children, hospital, health care, injectors are grown from the breeder after completion, they can be created by red supplementation from the effects such as rearing without completion . resistance children; aspiration is risky, wrong dose is administered. It is stated in relation to teachers and verbal medicines for health. Hansen et al. Working with 61 babies aged 0-24 months, using a pacifier injector and a normal injector, children and temperature monitors. They are from the nipple injector used by mothers and women. There is a need for a new modification in the existing oral drug applications that will be able to support the adaptation and readiness of the child and to be able to effectively administer the drug. This work; Two different methods used to give antipyretic (medication pacifier and colored injector) were planned to be performed as pain, fever and purpose of life (respiratory rate, planning CTA) for the child.
- Conditions
- Fever, Heart Rate, Respiratory Rate, Pain
- Being tested
- using a medicine pacifier to give acetaminophen
- Keywords
- children, oral medicine, medicine pacifier, injector, antipyretics
- Medical subject headings
- Fever, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using a medicine pacifier to give acetaminophenOther
While giving acetaminophen, the effect on the amount of taking the drug, pain and vital parameters are observed by using the drug pacifier.
| Study group | Role | What they receive |
|---|---|---|
| using a medicine pacifier to give acetaminophen | Experimental | Not described Receives: Other: using a medicine pacifier to give acetaminophen |
| using an enjector to give acetaminophen | Active comparator | Not described Receives: Other: using a medicine pacifier to give acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital parameters
Heart rate/minute
Measured: before oral medications
Secondary outcomes (1)
Pain score
Wong-baker pain scale. This scale is rated from 0 to 10. 0 is the pain of the pain, 10 is the pain to the beginning. shows. Pain by facial expression evaluation.
Measured: before oral medications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Nov 2020
- Primary completion30 Dec 2021
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sermin Dİnç, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366049
- Sponsor's protocol ID
- E-59491012-604.01.02-2973
- Status last verified
- Dec 2022
- First submitted
- 2 Apr 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dinc S, Gozen D. Oral Syringe Versus Drug Pacifier for Delivery of Oral Antipyretic Medication: A Randomized Controlled Trial. J Emerg Nurs. 2025 Sep;51(5):913-924. doi: 10.1016/j.jen.2025.04.006. Epub 2025 May 22.
PubMed 40407770
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Injector and Pacifier Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever
- ClinicalTrials.gov ID
- NCT05366049
- Acronym / sponsor ID
- E-59491012-604.01.02-2973
- Conditions
- Fever, Heart Rate, Respiratory Rate, Pain
- Keywords
- children, oral medicine, medicine pacifier, injector, antipyretics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 9 May 2022 (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.
Fever, one of the most common clinical journeys of childhood, makes up a fraction of emergency room admissions. About us-30. High fever, which is one of the first schools in infancy and childhood, can cause health problems such as not applying or starting the intervention. The most preferred method in the fire; antipyretic drug treatment in the hospital is routine . Antipyretics play a role in control plans and estimations of facts for cars of cars, the importance of word of mouth has some problems. In children, hospital, health care, injectors are grown from the breeder after completion, they can be created by red supplementation from the effects such as rearing without completion . resistance children; aspiration is risky, wrong dose is administered. It is stated in relation to teachers and verbal medicines for health. Hansen et al. Working with 61 babies aged 0-24 months, using a pacifier injector and a normal injector, children and temperature monitors. They are from the nipple injector used by mothers and women. There is a need for a new modification in the existing oral drug applications that will be able to support the adaptation and readiness of the child and to be able to effectively administer the drug. This work; Two different methods used to give antipyretic (medication pacifier and colored injector) were planned to be performed as pain, fever and purpose of life (respiratory rate, planning CTA) for the child.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| using a medicine pacifier to give acetaminophen | Experimental | Other: using a medicine pacifier to give acetaminophen |
| using an enjector to give acetaminophen | Active comparator | Other: using a medicine pacifier to give acetaminophen |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Applying to the pediatric emergency department with a complaint of high fever (38ºC).
- Being prescribed an antipyretic (paracetamol) by a physician.
- Those whose parents are literate and agree to participate in the study.
- Patients with triage color classification Yellow and Green.
- Children between 0-24 months will be included in the study.
Key exclusion criteria (4 listed)
- Having used antipyretics in the last 6 hours.
- Being prescribed an antipyretic other than paracetamol by the physician.
- Having trouble in sucking-swallowing coordination.
- Children with chronic disease and neuromotor developmental delay.
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 |
|---|---|---|
| using a medicine pacifier to give acetaminophenWhile giving acetaminophen, the effect on the amount of taking the drug, pain and vital parameters are observed by using the drug pacifier. | Other | using a medicine pacifier to give acetaminophen, using an enjector to give acetaminophen |
Primary outcome
Vital parameters
Time frame: before oral medications
Heart rate/minute
1 secondary outcome
Pain score
Time frame: before oral medications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 40407770Dinc S, Gozen D. Oral Syringe Versus Drug Pacifier for Delivery of Oral Antipyretic Medication: A Randomized Controlled Trial. J Emerg Nurs. 2025 Sep;51(5):913-924. doi: 10.1016/j.jen.2025.04.006. Epub 2025 May 22.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using a medicine pacifier to give acetaminophen in people with Fever and Heart Rate, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Dec 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital parameters (time frame: before oral medications). 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 NCT05366049, which also lists 1 linked publication.
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 22 Dec 2022.