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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Sucrose 24%

• Registration Number: NCT05323071
• Lead Sponsor: Oihana Lopez Alonso

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-02-14
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-12
• Study Completion: 2022-10-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Sucrose 24%	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.
Control Group	Sucrose 24%	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.

Primary Outcome Measures

Name	Time	Method
Pain during a painful procedure	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).

Trial Locations

Locations (1)

Hospital Universitario Araba-Sede Txagorritxu; 🇪🇸 Vitoria-Gasteiz, Alava, Spain