Abstract
To determine the effect of prophylactic AC on decreasing reactions after DTP vaccination, 261 children were assigned to receive prertBasured doses of a study medicine containing either AC or placebo (PL), in a double-blind randomized protocol. AC or PL was given before (0-30 min.), and 3, 7, 12 and 18 hrs after vaccination. Fever, local and systemic reactions were monitored at 3, 7, 12 and 24 hrs. Switching to open AC (OP) was allowed if the child had a temperature above 38.9°C or was in moderate pain. Completeness of study medicine use was (AC/PL): all 5 doses=78%/61%; ≥4 doses 87%/75%; ≥3 doses=96%/83%. Significant differences (p<0.05) between AC/PL were: T >38°C at 3 hrs=2%/11%; T >38°C at 6 hrs= 10%/32%; T ≥38°C at 12 Ers=19%/32%; fussiness 49%/71%, and severe pain at the vaccination site 6%/17%. Fewer parents in the AC group switched to OP due to fever or pain:14%/25%. Switching to OP occurred earlier in the PL group (mean 8.5 hrs) than in the AC group (mean 14.8 hrs). There were no significant differences between the two groups for fever ≥38.5°C, redness, swelling, induration, overall pain, fever ≥38°C at 24 hrs, drowsiness, anorexia, emesis, or crying ≥ ½ hr. Prophylactic AC as given in this study reduces the occurrence of fever, severe pain, and fussiness, but does not appear to modify other local and systemic reactions following DTP immunization.
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Lewis, K., Cherry, J., Sachs, M. et al. EFFECT OF PROPHYLACTIC ACEISMINOPHEN (AC) ON MODIFYING LOCAL AND SYSTEMIC REACTIONS TO DTP VACCINATION. Pediatr Res 21 (Suppl 4), 329 (1987). https://doi.org/10.1203/00006450-198704010-00973
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DOI: https://doi.org/10.1203/00006450-198704010-00973