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

NCT07784322 | Completed

• 1 other identifier: PAED-2026-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 1.Be screened for eligibility and have written informed consent provided by a parent or legal guardian before enrolment.
2. 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. 3.Undergo the clinically indicated heel-prick procedure according to standard SCBU practice.
4. 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. 5.Have heart rate and oxygen saturation monitored during the procedure.
6. 6.Have crying duration measured from the start of heel puncture until crying stops.

Conditions

Pain Control in Heel Prick Procedure

Keywords

Sucrose; Heel prick; Pain management

Outcome Measures

Primary Outcomes (1)

• Degree of changes in decreasing N-PASS pain score during heel prick procedure

  The N-PASS is a 10-point multidimensional scale that assesses five key domains, each scored from 0 to 2: Domain Score Crying/Irritability 0-2 Behavior/State 0-2 Facial Expression 0-2 Extremities/Tone 0-2 Vital Signs 0-2 Scoring Interpretation 0-2: Adequate pain control 3-6: Mild to moderate pain 7-10: Severe pain/agitation Only the pain/agitation scale (not sedation) was used, as sedated infants will be excluded by study protocol.

  The trained blind nurse will perform the N-PASS assessment and record physiological parameters as Baseline and during the heel-prick procedure (at heel puncture and during blood collection).

Secondary Outcomes (3)

• Crying Duration During Heel-Prick Procedure

  Baseline before procedure and during the heel-prick procedure.

• Change in Heart Rate During Heel-Prick Procedure

  Baseline and during the heel-prick procedure.

• Change in Oxygen Saturation During Heel-Prick Procedure

  Baseline and during the heel-prick procedure

Study Arms (3)

Arm 1: Low-dose sucrose 0.2 mL 24% Oral Sucrose

EXPERIMENTAL

Neonates will receive 0.2 mL of 24% oral sucrose solution approximately two minutes before a clinically indicated heel-prick procedure. An investigator nurse will slowly administer 0.2 mL of 24% oral sucrose solution onto the anterior tongue of the neonate approximately two minutes before the heel prick. The heel-prick procedure will then be performed according to the unit's standardized clinical procedure.

Dietary Supplement: 24% oral sucrose

Arm 2: Higher-dose sucrose 24% Oral Sucrose Solution, 0.5 mL

EXPERIMENTAL

Neonates will receive 0.5 mL of 24% oral sucrose solution approximately two minutes before a clinically indicated heel-prick procedure. An investigator nurse will slowly administer 0.5 mL of 24% oral sucrose solution onto the anterior tongue of the neonate approximately two minutes before the heel prick. The heel-prick procedure will then be performed according to the unit's standardized clinical procedure.

Dietary Supplement: 24% oral sucrose

Arm 3: Historical control Standard Non-pharmacological Care Without Sucrose

NO INTERVENTION

This retrospective historical control arm will include eligible neonates who underwent a heel-prick procedure before implementation of the oral sucrose protocol. These neonates received standard non-pharmacological pain-management measures without oral sucrose. No study intervention will be administered, and data will be obtained from existing medical records. During the historical data-collection period, neonates underwent clinically indicated heel-prick procedures without administration of oral sucrose. Standard non-pharmacological measures available under routine unit practice included swaddling, positioning, and non-nutritive sucking.

Interventions

24% oral sucrose DIETARY_SUPPLEMENT

Pain management from heel prick procedure

Arm 1: Low-dose sucrose 0.2 mL 24% Oral Sucrose; Arm 2: Higher-dose sucrose 24% Oral Sucrose Solution, 0.5 mL

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≥ 37 weeks.
• Aged between 0 hours to 28 days old.
• Requiring routine heel prick (e.g. newborn screening).
• Parents or legal guardians can read / understand Chinese or English

You may not qualify if:

• Diagnosed with severe congenital malformations, neurological disorders, or known metabolic disorders.
• Having received any sedatives or analgesics.
• Having feeding intolerance or gastrointestinal disease.

Sponsors & Collaborators

• Kwong Wah Hospital: lead

Study Sites (1)

Department of Paediatric, Hospital Authority

Kowloon, 0000, Hong Kong

Location

Related Publications (3)

• World Health Organization. (2016). WHO recommendations on newborn health: guidelines approved by the WHO Guidelines Review Committee. Geneva: World Health Organization.

  RESULT

• COMMITTEE ON FETUS AND NEWBORN and SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE. Prevention and Management of Procedural Pain in the Neonate: An Update. Pediatrics. 2016 Feb;137(2):e20154271. doi: 10.1542/peds.2015-4271. Epub 2016 Jan 25.

  PMID: 26810788 RESULT

• Stevens B, Yamada J, Campbell-Yeo M, Gibbins S, Harrison D, Dionne K, Taddio A, McNair C, Willan A, Ballantyne M, Widger K, Sidani S, Estabrooks C, Synnes A, Squires J, Victor C, Riahi S. The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial. BMC Pediatr. 2018 Feb 23;18(1):85. doi: 10.1186/s12887-018-1026-x.

  PMID: 29475433 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: For the prospective RCT, neonates will be randomly allocated in a 1:1 ratio to receive either 0.2 ml or 0.5 ml of 24% sucrose solution using a computer-generated randomization sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher not involved in the study. The research team comprises three experienced members: a supervisor nurse (overseeing and administering the intervention), a case nurse (assessing pain), and a phlebotomist (performing the heel prick). The supervisor nurse will prepare and administer the blinded sucrose solutions. The case nurse, phlebotomist and data analyst will remain blind to allocation. Parents / legal guardians will not be present during the procedure to maintain blinding. The historical control group will be non-randomized and non-concurrent; blinding will be not applicable, but N-PASS score will be assessed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Consultant (Neonatal Care), Principal Investigator.

Model Details: Randomization Method: Computer-generated randomization to ensure equal distribution across arms Stratification: baseline pain sensitivity Outcome Measures: Validated neonatal pain scales N-PASS, crying duration, physiological parameters (heart rate, oxygen saturation) Sample Size: Calculated based on expected effect size between groups with appropriate power (typically 80-90%) Historical Controls: an observational cohort comparison component

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 25, 2026
• Study Start: April 13, 2026
• Primary Completion: July 23, 2026
• Study Completion: July 23, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)