title: A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants.
abstract: BACKGROUND
  Fever 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.
  
  
  METHODS
  Children 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.
  
  
  RESULTS
  A 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).
  
  
  CONCLUSIONS
  The results of this relatively small trial suggest that acetaminophen may reduce the risk of post-vaccination fever and fussiness.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00325819.
authors.affiliation: Group Health Research Institute, Seattle, Washington, United States of America. Jackson.L@ghc.org
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Jackson
authors.forename: Do
authors.initials: D
authors.lastname: Peterson
authors.forename: John
authors.initials: J
authors.lastname: Dunn
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Hambidge
authors.forename: Maya
authors.initials: M
authors.lastname: Dunstan
authors.forename: Patty
authors.initials: P
authors.lastname: Starkovich
authors.forename: Onchee
authors.initials: O
authors.lastname: Yu
authors.forename: Joyce
authors.initials: J
authors.lastname: Benoit
authors.forename: Clara P
authors.initials: CP
authors.lastname: Dominguez-Islas
authors.forename: Barbara
authors.initials: B
authors.lastname: Carste
authors.forename: Patti
authors.initials: P
authors.lastname: Benson
authors.forename: Jennifer C
authors.initials: JC
authors.lastname: Nelson
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage* / Q000627:therapeutic use; D005334:Fever / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D010567:Pertussis Vaccine / Q000009:adverse effects*; D010919:Placebos; D018401:Sample Size
chemical_list: D010567:Pertussis Vaccine; D010919:Placebos; D000082:Acetaminophen