NCT05366049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

April 2, 2022

Last Update Submit

December 20, 2022

Conditions

Keywords

children, oral medicine, medicine pacifier, injector, antipyretics

Outcome Measures

Primary Outcomes (1)

  • Vital parameters

    Heart rate/minute

    before oral medications

Secondary Outcomes (1)

  • Pain score

    before oral medications

Other Outcomes (18)

  • vital parameters

    before oral medications

  • vital parameters

    before oral medications

  • Vital parameters

    after medications 15 minute

  • +15 more other outcomes

Study Arms (2)

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

Interventions

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

using a medicine pacifier to give acetaminophenusing an enjector to give acetaminophen

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Unisversity- Cerrahpasa

Istanbul, Fatih, 34320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FeverPain

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
single blind
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2022

First Posted

May 9, 2022

Study Start

November 1, 2020

Primary Completion

December 30, 2021

Study Completion

August 30, 2022

Last Updated

December 22, 2022

Record last verified: 2022-12

Locations