- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05366049
The Effect of Methods Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever
December 20, 2022 updated by: Sermin Dİnç, Istanbul University - Cerrahpasa (IUC)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fatih
-
İstanbul, Fatih, Turkey, 34320
- Istanbul Unisversity- Cerrahpasa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: using 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.
|
|
Active Comparator: using an enjector 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vital parameters
Time Frame: before oral medications
|
Heart rate/minute
|
before oral medications
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score
Time Frame: before oral medications
|
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.
|
before oral medications
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
vital parameters
Time Frame: before oral medications
|
Respiratory rate/minute
|
before oral medications
|
|
vital parameters
Time Frame: before oral medications
|
fever measurement (degrees centigrade)
|
before oral medications
|
|
Vital parameters
Time Frame: after medications 15 minute
|
Heart rate/minute
|
after medications 15 minute
|
|
Vital parameters
Time Frame: after medications 30 minute
|
Heart rate/minute
|
after medications 30 minute
|
|
Vital parameters
Time Frame: after medications 45 minute
|
Heart rate/minute
|
after medications 45 minute
|
|
Vital parameters
Time Frame: after medications 60 minute
|
Heart rate/minute
|
after medications 60 minute
|
|
Pain score
Time Frame: after medications 15 minute
|
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.
|
after medications 15 minute
|
|
Pain score
Time Frame: after medications 30 minute
|
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.
|
after medications 30 minute
|
|
Pain score
Time Frame: after medications 45 minute
|
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.
|
after medications 45 minute
|
|
Pain score
Time Frame: after medications 60 minute
|
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.
|
after medications 60 minute
|
|
vital parameters
Time Frame: after medications 15 minute
|
Respiratory rate/minute
|
after medications 15 minute
|
|
vital parameters
Time Frame: after medications 30 minute
|
Respiratory rate/minute
|
after medications 30 minute
|
|
vital parameters
Time Frame: after medications 45 minute
|
Respiratory rate/minute
|
after medications 45 minute
|
|
vital parameters
Time Frame: after medications 60 minute
|
Respiratory rate/minute
|
after medications 60 minute
|
|
vital parameters
Time Frame: after medications 15 minute
|
fever measurement (degrees centigrade)
|
after medications 15 minute
|
|
vital parameters
Time Frame: after medications 30 minute
|
fever measurement (degrees centigrade)
|
after medications 30 minute
|
|
vital parameters
Time Frame: after medications 45 minute
|
fever measurement (degrees centigrade)
|
after medications 45 minute
|
|
vital parameters
Time Frame: after medications 60 minute
|
fever measurement (degrees centigrade)
|
after medications 60 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Actual)
December 30, 2021
Study Completion (Actual)
August 30, 2022
Study Registration Dates
First Submitted
April 2, 2022
First Submitted That Met QC Criteria
May 4, 2022
First Posted (Actual)
May 9, 2022
Study Record Updates
Last Update Posted (Actual)
December 22, 2022
Last Update Submitted That Met QC Criteria
December 20, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-59491012-604.01.02-2973
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.