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IRCT2013070713889N1 IRCT 2013-12-22 Vice chancellor for research,Zahedan University of Medical Sciences Effect of injection order of the Diphtheria-Pertussis-Tetanus vaccine and Hepatitis B vaccine on pain in infants The comparison of injection order of the Diphtheria-Pertussis-Tetanus vaccine and Hepatitis B vaccine on pain response in infants 2012-12-21 anticipated 140 Complete https://irct.ir/trial/13626 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The is a single-blind, randomized clinical trial study, so that observer evaluating pain response was not aware of which vaccine had been administrated. Random selection was performed through placing letters A and B in envelope which was numbered for each participant as follows: ask mother of infants select one of these letters, letters A and B indicated of Intervention and Control group respectively. 1 The Pain of vaccine. Intervention 1: Intervention group: First the 0.5ml Hepatitis B vaccine manufactured by Pasteur Institute of Iran injected intramuscularly and then the 0.5ml DTP vaccine manufactured by Pasteur Company of Indonesia injected intramuscularly. Intervention 2: Control group: Routine order administered.(First the 0.5ml DTP vaccine manufactured by Pasteur Company of Indonesia injected intramuscularly and then the 0.5ml Hepatitis B vaccine manufactured by Pasteur Institute of Iran injected intramuscularly). http://www.magiran.com/magtoc.asp?mgID=6389&Number=14&Appendix=0&l=en 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
public Fatihe Kerman Saravi
Faculty of Nursing and Midwifery - Mashahir Square - Zahedan
Zahedan Iran (Islamic Republic of) +98 54 1241 1515 Fatihe @yahoo.com Zahedan University of Medical Sciences scientific Hasan Robabi
Faculty of Nursing and Midwifery - Mashahir Square - Zahedan
Zahedan Iran (Islamic Republic of) +98 54 1244 8584 harobabi@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) 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. 2 years 3 years Both M79.6 pain in limb Prevention N/A Intervention group: First the 0.5ml Hepatitis B vaccine manufactured by Pasteur Institute of Iran injected intramuscularly and then the 0.5ml DTP vaccine manufactured by Pasteur Company of Indonesia injected intramuscularly. Control group: Routine order administered.(First the 0.5ml DTP vaccine manufactured by Pasteur Company of Indonesia injected intramuscularly and then the 0.5ml Hepatitis B vaccine manufactured by Pasteur Institute of Iran injected intramuscularly) Behavioral pain responses. Timepoint: Immediately after vaccine injection until 15 seconds. Method of measurement: Modified Behavioral Pain Scale (MBPS). 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). Vice chancellor for research,Zahedan University of Medical Sciences Approved 2012-09-26 Ethics committee of Zahedan University of Medical Sciences Vice Chancellor for research, Zahedan University of Medical Sciences -Dr Hesabi Square- Zahedan Zahedan Iran (Islamic Republic of)