IBUPROFEN PROPHYLAXIS FOR ADVERSE REACTIONS TO DIPHTHERIA-TETANUS-PERTUSSIS VACCINATION - A RANDOMIZED TRIAL

The aim of this study was to determine the effectiveness of ibuprofen prophylaxis in reducing the adverse effects of diphtheria-tetanus-pert ussis (DTP) and oral polio vaccination in children 3, 5, and 7 months of age and to compare its effects with those of the present policy of treating adverse reactions when they occur. This 12-month, multicenter , randomized, open-label trial was conducted in six ambulatory, primar y care centers. A total of 256 healthy children aged 3 months (+/-15 d ays) receiving DTP vaccine were studied at that age and at 5 and 7 mon ths (ie, at the second and third DPT doses). Adverse effects of 719 va ccine doses were studied; 219 infants received all three doses. Patien ts were randomized to receive either ibuprofen prophylaxis (20 mg/kg p er day in three equally divided doses over 24 hours, the first dose gi ven together with the vaccine) or treatment (ibuprofen 7.5 mg/kg) for the adverse reactions when they occurred. The same therapeutic regimen was followed after the second and third DTP doses. Adverse effects af ter immunization were recorded by parents or guardians in a previously validated questionnaire and included elevated rectal temperature, sys temic reactions (crying, drowsiness, fretfulness, vomiting, diarrhea, and anorexia), and local reactions (redness, edema, induration, and pa in). None of the patients were withdrawn from the study because of adv erse effects. The results of the study suggest that children given ibu profen prophylaxis had temperature increases after DTP vaccination sim ilar to those who received treatment when reactions occurred, but they had fewer systemic and local effects. No remarkable adverse effects s uch as seizures, collapse, or shock-like state (hypotonic-hyporesponse episodes) occurred. One sterile abscess was seen at the injection sit e in the prophylaxis group. Thus ibuprofen prophylaxis after DTP vacci nation at 3, 5, and 7 months of age slightly decreased the occurrence of systemic and local adverse effects but did not reduce temperature.