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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-10-11

Brief Summary

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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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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

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.

Group Type ACTIVE_COMPARATOR

Sucrose 24%

Intervention Type 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

Experimental Group

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.

Group Type EXPERIMENTAL

Sucrose 24%

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes