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.

Oihana Lopez Alonso1 site in 1 country74 target enrollmentSeptember 1, 2021

ConditionsPain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pain
Sponsor: Oihana Lopez Alonso
Enrollment: 74
Locations: 1
Primary Endpoint: Pain during a painful procedure
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 1, 2021

End Date

October 11, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oihana Lopez Alonso

Responsible Party

Sponsor Investigator

Principal Investigator

Oihana Lopez Alonso

Neonatal unit nurse

Bioaraba Health Research Institute

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Pain during a painful procedure

Time Frame: 15 seconds after extraction

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).