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

Primary Purpose

Fever, Heart Rate, Respiratory Rate

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
using a medicine pacifier to give acetaminophen
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fever focused on measuring children, oral medicine, medicine pacifier, injector, antipyretics

Eligibility Criteria

undefined - 24 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Istanbul Unisversity- Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

using a medicine pacifier to give acetaminophen

using an enjector to give acetaminophen

Arm Description

Outcomes

Primary Outcome Measures

Vital parameters
Heart rate/minute

Secondary Outcome Measures

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.

Full Information

First Posted
April 2, 2022
Last Updated
December 20, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05366049
Brief Title
The Effect of Methods Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever
Official Title
The Effect of Injector and Pacifier Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Heart Rate, Respiratory Rate, Pain
Keywords
children, oral medicine, medicine pacifier, injector, antipyretics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
single blind
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
using a medicine pacifier to give acetaminophen
Arm Type
Experimental
Arm Title
using an enjector to give acetaminophen
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
using a medicine pacifier to give acetaminophen
Intervention Description
While giving acetaminophen, the effect on the amount of taking the drug, pain and vital parameters are observed by using the drug pacifier.
Primary Outcome Measure Information:
Title
Vital parameters
Description
Heart rate/minute
Time Frame
before oral medications
Secondary Outcome Measure Information:
Title
Pain score
Description
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 Pre-specified Outcome Measures:
Title
vital parameters
Description
Respiratory rate/minute
Time Frame
before oral medications
Title
vital parameters
Description
fever measurement (degrees centigrade)
Time Frame
before oral medications
Title
Vital parameters
Description
Heart rate/minute
Time Frame
after medications 15 minute
Title
Vital parameters
Description
Heart rate/minute
Time Frame
after medications 30 minute
Title
Vital parameters
Description
Heart rate/minute
Time Frame
after medications 45 minute
Title
Vital parameters
Description
Heart rate/minute
Time Frame
after medications 60 minute
Title
Pain score
Description
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
Title
Pain score
Description
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
Title
Pain score
Description
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
Title
Pain score
Description
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
Title
vital parameters
Description
Respiratory rate/minute
Time Frame
after medications 15 minute
Title
vital parameters
Description
Respiratory rate/minute
Time Frame
after medications 30 minute
Title
vital parameters
Description
Respiratory rate/minute
Time Frame
after medications 45 minute
Title
vital parameters
Description
Respiratory rate/minute
Time Frame
after medications 60 minute
Title
vital parameters
Description
fever measurement (degrees centigrade)
Time Frame
after medications 15 minute
Title
vital parameters
Description
fever measurement (degrees centigrade)
Time Frame
after medications 30 minute
Title
vital parameters
Description
fever measurement (degrees centigrade)
Time Frame
after medications 45 minute
Title
vital parameters
Description
fever measurement (degrees centigrade)
Time Frame
after medications 60 minute

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Istanbul Unisversity- Cerrahpasa
City
İstanbul
State/Province
Fatih
ZIP/Postal Code
34320
Country
Turkey

12. IPD Sharing Statement

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

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