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-pertussis (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, primary care centers. A total of 256 healthy children aged 3 months (+/-15 days) receiving DTP vaccine were studied at that age and at 5 and 7 months (ie, at the second and third DPT doses). Adverse effects of 719 vaccine doses were studied; 219 infants received all three doses. Patients were randomized to receive either ibuprofen prophylaxis (20 mg/kg per day in three equally divided doses over 24 hours, the first dose given 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 after immunization were recorded by parents or guardians in a previously validated questionnaire and included elevated rectal temperature, systemic reactions (crying, drowsiness, fretfulness, vomiting, diarrhea, and anorexia), and local reactions (redness, edema, induration, and pain). None of the patients were withdrawn from the study because of adverse effects. The results of the study suggest that children given ibuprofen prophylaxis had temperature increases after DTP vaccination similar to those who received treatment when reactions occurred, but they had fewer systemic and local effects. No remarkable adverse effects such as seizures, collapse, or shock-like state (hypotonic-hyporesponse episodes) occurred. One sterile abscess was seen at the injection site in the prophylaxis group. Thus ibuprofen prophylaxis after DTP vaccination at 3, 5, and 7 months of age slightly decreased the occurrence of systemic and local adverse effects but did not reduce temperature.