Ensaio clínico randomizado para avaliação dos eventos adversos da vacina pentavalente em lactentes de Goiânia-Go

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Universidade Federal de Goiás
The development of vaccines led to an increase in administration by intramuscular route on the vastus lateralis (VL) region of the thigh, a site that has been recommended by the Ministry of Health since 1993 and which is the most commonly used by professionals, and produces greater pain and more local adverse events. The ventrogluteal (VG) region, however, has been pointed out by many researchers as an alternative and immunogenic location for the application of drugs in children younger than two years of age. Thus, a safe location and which produces less suffering in the administration of vaccines is needed. OBJECTIVE: The aim of this study was to assess the pain and adverse events of the pentavalent vaccine (DTP/HB-Hib) administered in children assisted at a healthcare unit in the city of Goiânia, in the Brazilian state of Goiás, comparing the VG and the VL regions. METHODS: A randomized, controlled clinical trial of phase IV was conducted to assess the pain and adverse events associated with the application of the DTP/HBHib vaccine in the VL (comparison group) and the VG (intervention group) regions in children younger than two years of age. Pain was assessed before, at the time of application, and at one minute and three minutes after the vaccine, using the FLACC scale. Adverse events were assessed between 48 and 72 hours after the vaccine in the home of the children. Data were analyzed using the SPSS statistical program, descriptive statistics by means of arithmetic mean and standard deviation, and a Student’s t-test. Scores were considered statistically significant at p<0.05. This project was funded by FAPEG, PPPedict, and number 06/09 with Research Ethics Committee of Federal University of Goiás, registered CEP/UFG n◦052/12. RESULTS: Pain was assessed in 252 children and adverse events in 211 children. The two groups were comparable children characteristics (regarding gender, history of diseases, place of birth, maternal education, marital status of mother and family income, age, previous injections, period of exclusive breastfeeding and maternal age). The intensity of pain assessed in the children before the vaccine was similar in both groups, but it was lower in the children vaccinated in the VG region than in those vaccinated in the VL region (p=0.00) in the three moments during and after the vaccination. The adverse event induration was also more present in the VL than in the VG region (p=0.002). CONCLUSION: The evidences in this article increases the knowledge among health professionals about the applicability of administration technique in the VG region, reducing injuries in children vaccination and shows VG region as the best option for immunogens application in children regarding their safety, less pain during and after the injection and less local reaction.
JUNQUEIRA, Priscilla dos Santos. Ensaio clínico randomizado para avaliação dos eventos adversos da vacina pentavalente em lactentes de Goiânia-Go. 2015. 88 f. Dissertação (Programa de Pós-graduação em Enfermagem) - Universidade Federal de Goiás, Goiânia, 2014.