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A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants.

ABSTRACT: 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.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.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).The results of this relatively small trial suggest that acetaminophen may reduce the risk of post-vaccination fever and fussiness.Clinicaltrials.gov NCT00325819.

SUBMITTER: Jackson LA

PROVIDER: S-EPMC3117800 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants.

Jackson Lisa A LA Peterson Do D Dunn John J Hambidge Simon J SJ Dunstan Maya M Starkovich Patty P Yu Onchee O Benoit Joyce J Dominguez-Islas Clara P CP Carste Barbara B Benson Patti P Nelson Jennifer C JC

PloS one 20110617 6

<h4>Background</h4>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.<h4>Methods</h4>Children six weeks through nine months of age were randomized 1:1 to receive up to five doses of acetaminophen (10-1 ...[more]

PMID: 21698100

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Project description:BACKGROUND: Bronchiolitis is a major health burden in infants globally, particularly among Indigenous populations. It is unknown if 3?weeks of azithromycin improve clinical outcomes beyond the hospitalization period. In an international, double-blind randomized controlled trial, we determined if 3?weeks of azithromycin improved clinical outcomes in Indigenous infants hospitalized with bronchiolitis. METHODS: Infants aged ?24?months were enrolled from three centers and randomized to receive three once-weekly doses of either azithromycin (30?mg/kg) or placebo. Nasopharyngeal swabs were collected at baseline and 48?h later. Primary endpoints were hospital length of stay (LOS) and duration of oxygen supplementation monitored every 12?h until judged ready for discharge. Secondary outcomes were: day-21 symptom/signs, respiratory rehospitalizations within 6?months post-discharge and impact upon nasopharyngeal bacteria and virus shedding at 48?h. RESULTS: Two hundred nineteen infants were randomized (n?=?106 azithromycin, n?=?113 placebo). No significant between-group differences were found for LOS (median 54?h for each group, difference?=?0?h, 95% CI: -6, 8; p?=?0.8), time receiving oxygen (azithromycin?=?40?h, placebo?=?35?h, group difference?=?5?h, 95% CI: -8, 11; p?=?0.7), day-21 symptom/signs, or rehospitalization within 6?months (azithromycin n?=?31, placebo n?=?25 infants, p?=?0.2). Azithromycin reduced nasopharyngeal bacterial carriage (between-group difference 0.4 bacteria/child, 95% CI: 0.2, 0.6; p?<?0.001), but had no significant effect upon virus detection rates. CONCLUSION: Despite reducing nasopharyngeal bacterial carriage, three large once-weekly doses of azithromycin did not confer any benefit over placebo during the bronchiolitis illness or 6?months post hospitalization. Azithromycin should not be used routinely to treat infants hospitalized with bronchiolitis. CLINICAL TRIAL REGISTRATION: The trial was registered with the Australian and New Zealand Clinical Trials Register: Clinical trials number: ACTRN1261000036099.

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A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants.

Publications

A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants.

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