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Comparing 0.2 ml and 0.5 ml Oral 24% Sucrose Solution for Pain Relief During Heel Prick in Neonates With Historical Controls

NCT07784322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-08-25

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether a lower dose of oral 24% sucrose solution provides pain relief that is non-inferior to a higher dose during routine heel-prick procedures in term neonates. The study will include neonates aged 0 to 28 days, born at ≥37 weeks of gestation, admitted to the Special Care Baby Unit and requiring a routine heel prick.

The main questions it aims to answer are:

Is 0.2 mL of 24% oral sucrose non-inferior to 0.5 mL of 24% oral sucrose in reducing N-PASS pain scores during heel prick?

Does 0.2 mL versus 0.5 mL of 24% oral sucrose differ in crying duration or changes in physiological parameters, including heart rate and oxygen saturation, during the procedure?

Researchers will compare neonates randomized to receive 0.2 mL of 24% oral sucrose with neonates randomized to receive 0.5 mL of 24% oral sucrose to determine whether the lower dose provides comparable procedural pain relief. The two prospective sucrose groups will also be compared with a retrospective historical control group of eligible neonates who received standard non-pharmacological care without oral sucrose during heel-prick procedures.

Participants will:

1. Be screened for eligibility and have written informed consent provided by a parent or legal guardian before enrolment.
2. Be randomly assigned to receive 0.2 mL or 0.5 mL of 24% oral sucrose solution approximately two minutes before the heel prick.
3. Undergo the clinically indicated heel-prick procedure according to standard SCBU practice.
4. Have pain assessed by a trained nurse blinded to treatment allocation using the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) before sucrose administration and during heel puncture/blood collection.
5. Have heart rate and oxygen saturation monitored during the procedure.
6. Have crying duration measured from the start of heel puncture until crying stops.

Conditions

  • Pain Control in Heel Prick Procedure

Interventions

DIETARY_SUPPLEMENT

24% oral sucrose

Pain management from heel prick procedure

Sponsors & Collaborators

  • Kwong Wah Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2026-07-23
Completion
2026-07-23

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784322 on ClinicalTrials.gov