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

Recruiting

• Conditions: comparison of pain relief with breastfeeding and 25% dextrose during immunization with pentavalent vaccine in healthy infants

• Registration Number: CTRI/2014/07/004724
• Lead Sponsor: MOSC MEDICAL COLLEGE

Brief Summary

This study is a randomized, open label, parallel group, single centre trial, comparing the efficacy of breastfeeding and 25% oral dextrose for pain relief during immunization with pentavalent vaccine in healthy infants. Infants will be randomized by computer generated permuted block randomization into one of two groups: group A- Breastfeeding (40 infants). Group B- 25% dextrose (40 infants) after receiving written informed consent from the mother. Allocation concealment will be acheived using sequentially numbered opaque sealed envelopes. Demographic data of infants will be collected. In the breastfeeding group, infants will be breastfed throughout the intervention, starting two minutes prior to the vaccination. In group B, infants will receive 2ml 25% dextrose solution orally, with the help of a sterile syringe, 2 minutes before the vaccination. A qualified nurse practitioner will prepare the infant and administer the pentavalent vaccine.The outcome variable will be the acute behavioral pain response assessed using the FLACC Scale, immediately, and after 1 and 3 minutes of needle insertion. The assessment will be done by the primary investigator.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-15
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• 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 infants	The FLACC Score will be calculated immediately,and after 1 and 3 minutes of needle insertion.

Trial Locations

Locations (1)

MOSC MEDICAL COLLEGE; 🇮🇳 Ernakulam, KERALA, India

MOSC MEDICAL COLLEGE

🇮🇳Ernakulam, KERALA, India

Dr ABRAHAM PAULOSE

Principal investigator

9495037152

drabrahampaulose@hotmail.com