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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05323071

Enrollment

Registered

2022-04-12

Start date

2021-09-01

Completion date

2022-10-11

Last updated

2023-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

OTHERSucrose 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

32 Weeks to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026