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Comparing the efficacy of breast milk and sweet solution in reducing pain during blood sampling in newborn babies

Comparing the efficacy of breast milk and dextrose solutions in reducing procedural pain during venipuncture in neonates - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090168
Enrollment
135
Registered
2025-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: R52- Pain, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: 25% Dextrose: Administration of 2 ml of 25% dextrose orally by a paladai in 2 minutes by a staff nurse. She will clean excess solution, remove the paladai and en

Sponsors

Nikunj Bhatnagar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All vitally stable newborns of greater or equal to 37 weeks gestation who are on exclusive breast feeding and have been admitted for phototherapy for jaundice requiring routine sampling of total serum bilirubin by venepuncture

Exclusion criteria

Exclusion criteria: Neonates with 1. Cerebral injury in form of perinatal asphyxia / hypoxic-ischemic encephalopathy / meningitis / bilirubin induced neuro-disability 2. Any obvious congenital malformation like cleft palate, cleft lip. 3. Requiring more than one prick 4. Who have passed stools during procedure 5. Who are small for gestational age or large for gestational age

Design outcomes

Primary

MeasureTime frame
Measures the PIPP score of babies during venepuncture in 2 ml D-25% or 5 ml D-10% or 7 ml expressed breast milk groupsTimepoint: The principal investigator will record the PIPP score during venepuncture of baby, which will be recorded in the patient proforma.—

Secondary

MeasureTime frame
Record the changes in Heart rate, Respiratory rate, SpO2 & RBS measurement after 1 hour of administration of 2 ml D-25% or 5 ml D-10% or 7 ml expressed breast milkTimepoint: The observer will be recording the vital which will include heart rate, respiratory rate, SpO2. This measurement will be done at baseline (before venepuncture & before administration of test solution [intervention]), 0 minutes (during venepuncture), 1 minute, 3 minutes & 5 minutes after venepuncture. The observer will also measure the RBS (random blood sugar) by heel prick 1 hour after administration of test solution.—

Countries

India

Contacts

Public ContactNikunj Bhatnagar

ESIC Hospital and PGIMSR, Basaidarapur

nikunjbhatnagar10@gmail.com7982945101

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026