The Effect of Antipyretics Given by Two Different Methods on the Pain and Vital Parameters of the Child

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05366049
Collaborator
(none)
100
1
2
21.9
4.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: using a medicine pacifier to give acetaminophen
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trialrandomized controlled trial
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
single blind
Primary Purpose:
Other
Official Title:
The Effect of Antipyretics Given by Two Different Methods on the Pain and Vital Parameters of the Child
Actual Study Start Date :
Nov 1, 2020
Actual Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Vital parameters [before oral medications]

    Heart rate/minute

Secondary Outcome Measures

  1. Pain score [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.

Other Outcome Measures

  1. vital parameters [before oral medications]

    Respiratory rate/minute

  2. vital parameters [before oral medications]

    fever measurement (degrees centigrade)

  3. Vital parameters [after medications 15 minute]

    Heart rate/minute

  4. Vital parameters [after medications 30 minute]

    Heart rate/minute

  5. Vital parameters [after medications 45 minute]

    Heart rate/minute

  6. Vital parameters [after medications 60 minute]

    Heart rate/minute

  7. Pain score [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.

  8. Pain score [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.

  9. Pain score [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.

  10. Pain score [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.

  11. vital parameters [after medications 15 minute]

    Respiratory rate/minute

  12. vital parameters [after medications 30 minute]

    Respiratory rate/minute

  13. vital parameters [after medications 45 minute]

    Respiratory rate/minute

  14. vital parameters [after medications 60 minute]

    Respiratory rate/minute

  15. vital parameters [after medications 15 minute]

    fever measurement (degrees centigrade)

  16. vital parameters [after medications 30 minute]

    fever measurement (degrees centigrade)

  17. vital parameters [after medications 45 minute]

    fever measurement (degrees centigrade)

  18. vital parameters [after medications 60 minute]

    fever measurement (degrees centigrade)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 24 Months
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Unisversity- Cerrahpasa İstanbul Fatih Turkey 34320

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sermin Dİnç, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT05366049
Other Study ID Numbers:
  • E-59491012-604.01.02-2973
First Posted:
May 9, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sermin Dİnç, Principal Investigator, Istanbul University-Cerrahpasa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2022