A clinical trial to study the effect of breastfeeding and 25% oral dextrose for pain relief during immunization of infants
Not Applicable
- Registration Number
- CTRI/2014/07/004724
- Lead Sponsor
- MOSC MEDICAL COLLEGE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 80
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ILTimepoint: NI