A Randomized Placebo-Controlled Trial of Acetaminophen for Prevention of Post-Vaccination Fever in Infants
2011

Acetaminophen for Preventing Fever After Vaccination in Infants

Sample size: 352 publication 10 minutes Evidence: moderate

Author Information

Author(s): Lisa A. Jackson, Do Peterson, John Dunn, Simon J. Hambidge, Maya Dunstan, Patty Starkovich, Onchee Yu, Joyce Benoit, Clara P. Dominguez-Islas, Barbara Carste, Patti Benson, Jennifer C. Nelson

Primary Institution: Group Health Research Institute, Seattle, Washington, United States of America

Hypothesis

Does acetaminophen prophylaxis reduce the risk of post-vaccination fever in infants receiving routine vaccinations?

Conclusion

The study suggests that acetaminophen may reduce the risk of post-vaccination fever and fussiness in infants.

Supporting Evidence

  • 14% of children receiving acetaminophen had a temperature ≥38°C compared to 22% in the placebo group.
  • Children receiving acetaminophen were less likely to be reported as much more fussy than usual (10% vs 24%).
  • In older infants (≥24 weeks), acetaminophen significantly reduced the risk of fever (13% vs 25%).

Takeaway

This study looked at whether giving babies acetaminophen after vaccinations helps prevent fever. It found that it might help a little, but not enough to be sure.

Methodology

Infants aged 6 weeks to 9 months were randomized to receive acetaminophen or placebo after vaccinations, and their temperatures were monitored.

Potential Biases

Potential bias in reporting outcomes due to parental expectations and unblinding requests.

Limitations

The study was stopped before reaching the intended sample size, which may limit the power of the findings.

Participant Demographics

Infants aged 6 weeks to 9 months, with a mean age of 24.5 weeks.

Statistical Information

P-Value

0.03

Confidence Interval

95% CI, 0.40–1.01

Statistical Significance

p=0.03

Digital Object Identifier (DOI)

10.1371/journal.pone.0020102

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