The clinical trial, “A Randomized Placebo-Controlled Trial of Acetaminophen for Prevention of Post-Vaccination …show more content…
aimed to investigate the efficacy and safety of prophylactic acetaminophen in children administered various types of injected vaccinations. Participants of the study were to be healthy, >4,000 g at enrollment, and within the age range of 56-112 days at the time of enrollment. Children were excluded if they were immunodeficient or immunosuppressed, had history of seizures or bleeding disorders, were previously vaccinated or given blood products, had intolerance to acetaminophen, or if their gestational age was 39°C after each dose. Safety endpoints were compared using a 2-sided Fisher exact test. A sample size of 120 infants would give a ≥95% power (alpha=0.05, 2 sided). Therefore, 148 infants were assigned to the acetaminophen group, and 153 were assigned to the control group. Reduction of risk in the infant group was computed to be 43% efficient (95% confidence interval [CI]: 17.4,