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A clinical trial to study the effect of breastfeeding and 25% oral dextrose for pain relief during immunization of infants

Comparison of breastfeeding and 25% oral dextrose for pain relief during immunization of infants: a randomized controlled trial - BFODPR

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/07/004724
Enrollment
80
Registered
2014-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Oral 25% dextrose: 2ml 25% dextrose orally given 2 minutes before immunization with pentavalent vaccine in healthy infants below 6 months of age. Control Intervention1: Breastfeeding: b

Sponsors

MOSC MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy infants born at 37 to 42 weeks of gestation, with birth weight 2.5 kilos or more. Exclusively or partially breastfed, attending immunization clinic of this institution for primary vaccination with pentavalent vaccine. All infants will be fed within 3 hours and over 30 minutes prior to the intervention.

Exclusion criteria

Exclusion criteria: Infants with current illness. Unable to tolerate fluids by mouth. Cerebral palsy where response to pain stimuli may be altered. History of perinatal asphyxia. Congenital malformations and developmental delay.

Design outcomes

Primary

MeasureTime frame
Acute behavioral pain response assessed using a composite score obtained from the Face Legs Activity Cry Consolability(FLACC)Scale for infantsTimepoint: The FLACC Score will be calculated immediately,and after 1 and 3 minutes of needle insertion.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr ANNA MATHEW

MOSC MEDICAL COLLEGE

350south@gmail.com9442221950

Outcome results

None listed

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