Background: Parents worry about the complications of DTP vaccine. However, there are some reports demonstrating the positive effect of acetaminophen on DTP vaccine complications. The present study was conducted on children referring to Kashan health care centers to determine the role of acetaminophen on the complications of DTP vaccine.

Materials and methods : For this clinical trial, 324 children aged 1.5month-6 years who had received DTP vaccine produced by Razi institute in 1378 were selected. They were assigned randomly in two groups of case and control. The case group have received acetaminophen at the dosage of 15mg/kg/dose at the time of vaccine injection and then each 6 hours for 48 hours. Then, complications were recorded after 48 hours and analyzed by chi square.

Results : Groups were matched according to the sex and age. Of 324 children, 281 (86.7%) developed complications. This was 88.9% for the control and 84.6% for the case group, respectively (NS). Fever was the most common complication (66.1% for the control vs. 46.9% for the case group, p<0.0007). On the other hand, pain at the site of injection was the most common local complication occurred in 58% of controls and 35.21% of cases (p<0.0001).

Conclusion : Acetaminophen may reduce some complications of DTP vaccine, thus, it is recommended following the vaccine injection.