Relationship of order of vaccination with associated pain in infant

Comparison of antinociceptive effect of order of whole cell DTP and Hepatitis B vaccine in less than 4 months healthy infants

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/11/005207

Enrollment

130

Registered

2014-11-18

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: hepatitis B vaccine injection first followed by DTwP vaccine injection: 0.5 ml of hepatitis B vaccine (manufactured by biological E. limited) was administered intramuscular at anterolat

Eligibility

Inclusion criteria

Inclusion criteria: Full term healthy infants, less than four months of postnatal age, who attend immunization clinic for first wDPT vaccine according to universal immunization program

Exclusion criteria

Exclusion criteria: • All infants who have required hospital admission more than 48 hrs. • Perinatal asphyxia (1 min Apgar Score • Intra-uterine growth retardation (IUGR) i.e. wt • Pre-term deliveries. ( • Previous surgery • Any congenital anomaly • Any chronic medical conditions, • Allergy to any of the vaccine components • Concurrently receiving topical local anaesthetics

Design outcomes

Primary

Measure	Time frame
primary outcome was infant pain. Infant pain assessment was done by Modified facial coding System (MFCS) and Neonatal infant pain scale (NIPS)Timepoint: Pain score (MFCS and NIPS) were assessed prior to first vaccination, immediately after first vaccination, at 20-30 seconds after first vaccination, prior to second vaccination,immediately after second vaccination at 20-30 seconds after 2nd vaccination and at one minute after second vaccination.	—

Measure

Time frame

primary outcome was infant pain. Infant pain assessment was done by Modified facial coding System (MFCS) and Neonatal infant pain scale (NIPS)Timepoint: Pain score (MFCS and NIPS) were assessed prior to first vaccination, immediately after first vaccination, at 20-30 seconds after first vaccination, prior to second vaccination,immediately after second vaccination at 20-30 seconds after 2nd vaccination and at one minute after second vaccination.

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Secondary

Measure	Time frame
secondary outcome was heart rate ,saturation of oxygen(SPO2), and duration of cryTimepoint: Heart rate and SPO2 was assessed prior to,within 20-30 seconds of administration of both vaccine injection with TruscopeII multi utility Patient monitor(by Schiller).Duration of cry was assessed after first and second vaccine injection as first cry duration( maximum upto one minute after vaccine injection ),second cry duration (maximum upto 3 minutes after vaccine injection) respectively . Additionally total cry duration was calculated by adding first and second cry duration.	—

Measure

Time frame

secondary outcome was heart rate ,saturation of oxygen(SPO2), and duration of cryTimepoint: Heart rate and SPO2 was assessed prior to,within 20-30 seconds of administration of both vaccine injection with TruscopeII multi utility Patient monitor(by Schiller).Duration of cry was assessed after first and second vaccine injection as first cry duration( maximum upto one minute after vaccine injection ),second cry duration (maximum upto 3 minutes after vaccine injection) respectively . Additionally total cry duration was calculated by adding first and second cry duration.

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Countries

India

Contacts

Public ContactMITHILESH KUMAR

L.L.R.M COLLEGE,MEERUT

anuamit7@rediffmail.com9837405009

Outcome results