A Randomized Placebo-Controlled Trial of Acetaminophen for Prevention of Post-Vaccination Fever in Infants

Abstract

BackgroundFever is common following infant vaccinations. Two randomized controlled trials demonstrated the efficacy of acetaminophen prophylaxis in preventing fever after whole cell pertussis vaccination, but acetaminophen prophylaxis has not been evaluated for prevention of fever following contemporary vaccines recommended for infants in the United States.MethodsChildren six weeks through nine months of age were randomized 1∶1 to receive up to five doses of acetaminophen (10–15 mg per kg) or placebo following routine vaccinations. The primary outcome was a rectal temperature ≥38°C within 32 hours following the vaccinations. Secondary outcomes included medical utilization, infant fussiness, and parents' time lost from work. Parents could request unblinding of the treatment assignment if the child developed fever or symptoms that would warrant supplementary acetaminophen treatment for children who had been receiving placebo.ResultsA temperature ≥38°C was recorded for 14% (25/176) of children randomized to acetaminophen compared with 22% (37/176) of those randomized to placebo but that difference was not statistically significant (relative risk [RR], 0.63; 95% CI, 0.40–1.01). Children randomized to acetaminophen were less likely to be reported as being much more fussy than usual (10% vs 24%) (RR, 0.42; 95% CI, 0.25–0.70) or to have the treatment assignment unblinded (3% vs 9%) (RR, 0.31; 95% CI, 0.11–0.83) than those randomized to placebo. In age-stratified analyses, among children ≥24 weeks of age, there was a significantly lower risk of temperature ≥38°C in the acetaminophen group (13% vs. 25%; p = 0.03).ConclusionThe results of this relatively small trial suggest that acetaminophen may reduce the risk of post-vaccination fever and fussiness.Trial registrationClinicaltrials.gov NCT00325819

Effect of antipyretic analgesics on immune responses to vaccination

“…Furthermore, this prompted discontinuation of enrollment in a placebocontrolled randomized trial of acetaminophen given for prevention of post-vaccine fever in infants. 10 To date, routine administration of antipyretics around the time of vaccination is discouraged by many. 11 Despite this, the current CDC Vaccine Information Statement (VIS) for DTaP instructs caregivers to use antipyretics at time of vaccination and for the next 24 hours to reduce fever and pain; however, this has not been updated since its publication in 2007.…”

Systematic Review on the Relevancy of Paracetamol and Breastfeeding Post Infants Vaccination

“…All studies included age of babies from about six (6) weeks to around one (1) year of age (Rose et. al, 2013, Jackson et. al., 2011, Prymula et.…”

“…al., 2013 andUhari et. al., 1988) and only one (1) study evaluated baby condition (Jackson et. al., 2011) as well as only two (2) studies evaluated antibody of children (Prymula et.…”

“…The primary outcome measure for fever was made by parents completed the diary and/ questionnaires given by the researcher of the study, Among these four (4) studies, three (3) of them mentioned that they obtained approval from institutional ethics review board or committee (Rose et al, 2013, Jackson et. al, 2011and Prymula et.…”

“…(Jackson, Peterson, Dunn, Hambidge, Dunstan, Starkovich, Yu, Benoit, Dominguez-Islas, Carste, Benson, Nelson, 2011). The theoretical explanation was Paracetamol will inhibit the synthesis of Prostaglandin in the hypothalamus, thus inhibits the hypothalamic heat-regulating center and finally produces antipyeresis; as well as peripherally blocks pain impulse generation, thus producing analgesic effects (Drug Information Handbook, 2006).…”