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

Oihana Lopez Alonso

Status: Completed

Conditions: Pain

Treatments: Other: Sucrose 24%

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05323071

Expte. 2021-025

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 32+ weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Sucrose will be administered 2 minutes before the puncture following the current protocol of the unit. Venous or arterial puncture will be performed only in case it is required for therapeutic or care purposes.

Treatment:

Other: Sucrose 24%

Experimental Group

Experimental group

Description:

The administration of the sucrose dose is started by means of a syringe. Once 50% of the dose has been administered, puncture will be performed. The remaining 50% will be administered during the puncture. The pacifier will be left in the mouth until the end of the procedure, facilitating the non-nutritive sucking of the neonate.

Treatment:

Other: Sucrose 24%