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CompletedNCT05366049Updated Dec 22, 2022

The Effect of Methods Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever

An interventional study of using a medicine pacifier to give acetaminophen in Fever, Heart Rate and Respiratory Rate, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged Up to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-22.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Nov 2020, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
Up to 24 Months
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Fever
  • Heart Rate
  • Respiratory Rate
  • Pain

Browse trials for

Keywords

  • children, oral medicine, medicine pacifier, injector, antipyretics
03

In context

Fever

601 studies on the registry are indexed under Fever; 101 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 382 interventional studies indexed under Fever.

Browse Fever studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.

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

04

Who can participate

Ages eligible
Up to 24 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    using a medicine pacifier to give acetaminophen

    Other: using a medicine pacifier to give acetaminophen

  • Active comparator
    using an enjector to give acetaminophen

    Other: using a medicine pacifier to give acetaminophen

Interventions

  • Otherusing a medicine pacifier to give acetaminophen

    While giving acetaminophen, the effect on the amount of taking the drug, pain and vital parameters are observed by using the drug pacifier.

06

What researchers measure

Primary outcomes

  1. Vital parameters

    Heart rate/minute

    Time frame: 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.

    Time frame: before oral medications

Other outcomes

  1. vital parameters

    Respiratory rate/minute

    Time frame: before oral medications

  2. vital parameters

    fever measurement (degrees centigrade)

    Time frame: before oral medications

  3. Vital parameters

    Heart rate/minute

    Time frame: after medications 15 minute

  4. Vital parameters

    Heart rate/minute

    Time frame: after medications 30 minute

  5. Vital parameters

    Heart rate/minute

    Time frame: after medications 45 minute

  6. Vital parameters

    Heart rate/minute

    Time frame: after medications 60 minute

  7. 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.

    Time frame: after medications 15 minute

  8. 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.

    Time frame: after medications 30 minute

  9. 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.

    Time frame: after medications 45 minute

  10. 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.

    Time frame: after medications 60 minute

  11. vital parameters

    Respiratory rate/minute

    Time frame: after medications 15 minute

  12. vital parameters

    Respiratory rate/minute

    Time frame: after medications 30 minute

  13. vital parameters

    Respiratory rate/minute

    Time frame: after medications 45 minute

  14. vital parameters

    Respiratory rate/minute

    Time frame: after medications 60 minute

  15. vital parameters

    fever measurement (degrees centigrade)

    Time frame: after medications 15 minute

  16. vital parameters

    fever measurement (degrees centigrade)

    Time frame: after medications 30 minute

  17. vital parameters

    fever measurement (degrees centigrade)

    Time frame: after medications 45 minute

  18. vital parameters

    fever measurement (degrees centigrade)

    Time frame: after medications 60 minute

07

Study locations

1 site
  • Istanbul Unisversity- Cerrahpasa
    İstanbul, Fatih 34320, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05366049
Lead sponsor
Istanbul University - Cerrahpasa
Responsible party
Sermin Dİnç (Principal Investigator, Istanbul University - Cerrahpasa) — Principal investigator
First posted
May 9, 2022
Start date
Nov 1, 2020
Primary completion
Dec 30, 2021
Completion
Aug 30, 2022
Last update
Dec 22, 2022

Oversight

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

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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