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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: using a medicine pacifier to give acetaminophen
Other: 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vital parameters
Time Frame: before oral medications
Heart rate/minute
before oral medications

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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