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A STUDY ON ANALGESIC EFFECTS DURING VACCINATION IN HEALTHY TERM INFANTS

A STUDY ON THE ANALGESIC EFFECTS OF DIRECT BREASTFEEDING AND 24 %SUCROSE SOLUTION AGAINST A CONTROL GROUP DURING VACCINATION IN HEALTHY TERM INFANTS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035104
Enrollment
141
Registered
2021-07-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: 24%sucrose solution administration: In one of the three randomised groups, 24%sucrose solution is administered 2minutes prior to vaccination. This intervention is done only in one rand

Sponsors

DR AKHILA KURIAN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Term infants, who are exclusively or partially breastfed and attending the immunization clinic for infantrix Hexa(GSK) vaccination under 1 year of age (6weeks ) . Healthy, developmentally appropriate infants born at 37to 42 weeksââ?¬• gestation, with birth weight ââ?°Â¥2.5 kg, All infants should have been fed within three hours prior to the intervention, but shouldnââ?¬•t have had a feed in the past 30 minutes.

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA: Infants with a current illness -unable to tolerate fluids by mouth - with cerebral palsy where response to painful stimuli may be altered -with perinatal asphyxia with congenital malformations and developmental delay

Design outcomes

Primary

MeasureTime frame
The primary outcome variable- acute behavioural pain response, will be assessed using a composite score obtained from the modified behavioural pain score for infants. Timepoint: 2 years

Secondary

MeasureTime frame
Duration of cry ,latency of onset(from administration to onset of cry) - Heart rate measurement prior(5min) and post administration at 5 minutes - SpO2 monitoring will also be done at 5 minutes before and afterTimepoint: 10min

Countries

India

Contacts

Public ContactDR AKHILA KURIAN

MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE

drisacmathai2016@gmail.com9447036732

Outcome results

None listed

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