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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

32 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Araba-Sede Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sucrose 24%

Other

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

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).

Sponsors and collaborators

Lead sponsor

Oihana Lopez Alonso

Network

Registry information

Official study 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.

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Apr 12, 2022
Registry last updated: Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed