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NCT05323071 Clinical Trial

Comparison of the Efficacy of Oral Sucrose Administration at Two Different Times of a Painful Procedure in Neonates.

Pain Clinical Trial

Official title:
Comparison of the Effectiveness of Administering 24% Oral Sucrose Two Minutes Before Versus at the Same Time in the Performance of a Painful Procedure in the Neonate.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05323071
Other study ID # Expte. 2021-025
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date October 11, 2022

Study information
Verified date January 2023
Source Bioaraba Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to compare the use of 24% sucrose in pain control in neonates from 32 weeks of gestation onwards according to the time of administration of sucrose in venous and arterial puncture for blood collection.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date October 11, 2022
Est. primary completion date February 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 32 Weeks and older
Eligibility Inclusion Criteria: - Neonates whose parents and/or guardians have signed the informed consent form. Exclusion Criteria: - Neonates connected to invasive mechanical ventilation. - Neonates presenting any type of neurological alteration or showing signs of irritability prior to the puncture. - Neonates who have received sedation. - Neonates presenting withdrawal syndrome.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sucrose 24%
According to the age of the newborn: 24-26 weeks : 0.1 mL, 27-31weeks : 0.25 mL, 32-36 weeks : 0.5 mL, >37 weeks : 1 mL

Locations
Country Name City State
Spain Hospital Universitario Araba-Sede Txagorritxu Vitoria-Gasteiz Alava

Sponsors (1)
Lead Sponsor Collaborator
Oihana Lopez Alonso

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain during a painful procedure The primary variable is pain, and will be measured by the Premature Infant Pain Profile-Revised (PIPP-R) scale. The score ranges from 0 (no pain or minimal pain) to 21 (maximum pain). 15 seconds after extraction
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