MedPath

Effect of injection order of the Diphtheria-Pertussis-Tetanus vaccine and Hepatitis B vaccine on pain in infants

Phase 1
Conditions
The Pain of vaccine.
pain in limb
Registration Number
IRCT2013070713889N1
Lead Sponsor
Vice chancellor for research,Zahedan University of Medical Sciences
Brief Summary

Aims and Background: The most common invasive painful procedure during childhood is injective vaccination. Failure to relieve pain causes lack of timely referral for immunization and reduction of vaccine coverage. The purpose of this study was to determine the effect of injection order on infant''s pain response after diphtheria? pertussis? and tetanus (DTP) and hepatitis B vaccination.<br /> <br /> Methods and Materials: In this single-blind clinical trial study? 140 healthy infants with inclusion criteria at the age of 2 months referred to health centers of Zahedan city? Iran? during 2012 were randomly divided into two groups of control and intervention. In the control group? first the DTP vaccine and later? the hepatitis B vaccine were injected and in the intervention group? the order was vice versa. Using the Modified Behavioral Pain Scale (MBPS) and a demographic information checklist? the infant''s pain response was evaluated. Data were analyzed using descriptive statistics and independent t-test via SPSS15 software.<br /> <br /> Findings: The mean pain score after injecting hepatitis B vaccine was significantly less in the intervention group (7.12 ± 0.91) than injecting DTP vaccine in the control group (7.70 ± 0.62) (P = 0.001). The mean total pain score was significantly lower in the intervention group (7.59 ± 0.83) compared with the control group (8.27 ± 0.62) (P = 0.010).<br /> <br /> Conclusion: According to results of this study? to decrease pain during multiple immunizations in infants? injecting hepatitis B vaccine first and then? the DTP vaccine could be done.<br /> <br /> Keywords: Diphtheria, pertussis, and tetanus (DTP) vaccine, hepatitis B vaccine, pain, infants

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
140
Inclusion Criteria

Inclusion Criteria: 1. Healthy two month-old infants of both sexes with complete consciousness. 2. No history of surgery or hospitalization 3. Absence of chills, fever, diarrhea, etc. Exclusion criteria: taking analgesic or sedative drug 24 hours before vaccination by the infant or her mother.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Behavioral pain responses. Timepoint: Immediately after vaccine injection until 15 seconds. Method of measurement: Modified Behavioral Pain Scale (MBPS).
Secondary Outcome Measures
NameTimeMethod
Duration of crying. Timepoint: Immediately after vaccine injection up to time infants calm down or,maximum up to 3 minutes after injection. Method of measurement: Using stop watch(second).
© Copyright 2025. All Rights Reserved by MedPath