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A study to assess the pain relieving effects of Breast milk and a comparison of its effectiveness with that of sugar solution (oral sucrose) and a Placebo (Sterile water) in healthy newborns undergoing a painful procedure.

A Randomized controlled trial comparing the analgesic effects of expressed breast milk and oral sucrose during single painful procedures in neonates. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071269
Enrollment
90
Registered
2024-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

None listed

Interventions

Intervention1: Breastmilk: 2ml administered once, orally, 2 minutes prior to procedure. Control Intervention1: 24% Sucrose Solution: 2ml administered once, orally, 2 minutes prior to procedure. Contro

Sponsors

Pranav Agrawal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Clinically Stable Neonates of gestational age 35 weeks and above.

Exclusion criteria

Exclusion criteria: 1. Perinatal Asphyxia 2. Birth trauma 3. Cardiorespiratory instability, suspected or confirmed sepsis or Necrotising Enterocolitis 4. Any Apparent CNS Anomalies 5. Any Previous surgery 6. Maternal use of opioids, sedatives, analgesics 7. NICU Graduates 8. Consent not obtained 9. Use of Paracetamol or any other analgesics in the baby

Design outcomes

Primary

MeasureTime frame
To assess the effectiveness of breastmilk in reducing procedural pain in neonatesTimepoint: at Baseline, 30 seconds post procedure, and 5 minutes post procedure—

Secondary

MeasureTime frame
Comparing the analgesic effects of the three interventionsTimepoint: 30 seconds post procedure, 5 minutes post procedure;Comparison of changes in NIPS Pain Scores and Physiological Parameters between the three interventionsTimepoint: 30 seconds post procedure, 5 minutes post procedure—

Countries

India

Contacts

Public ContactPurnima S

BGS Global Institute of Medical Sciences

bgsgimspaed@gmail.com9902574134

Outcome results

None listed

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