Five randomised controlled trials (n=1,625) were included in the review.
Three randomised controlled trials (n=997) investigated the difference in adverse effects between acetaminophen and placebo for the DTwP vaccine; two studies found that in infants aged two to six months the overall incidence of fever (at least 38°C) and fussiness (irritability) were significantly decreased with acetaminophen. One trial reported a significant decrease in the overall incidence of high fever (at least 39°C), local redness greater than 2 cm, crying, moderate to severe pain and anorexia. One trial found no difference in fever or any other adverse reactions between placebo and treatment groups.
One randomised open-label study that investigated prophylactic ibuprofen versus control for the DTwP vaccine (n=256) found ibuprofen was associated with a significant improvement in crying, pain, fussiness, drowsiness and induration. The incidence of fever, redness, oedema, vomiting, diarrhoea and anorexia was no different between groups.
The one randomised controlled trial (n=372) that investigated acetaminophen and ibuprofen for the DTaP vaccine found no significant difference in adverse reactions between either treatment and placebo in the two days following vaccination. There was no difference in itchiness between groups during the six days after vaccination.