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

Jackson LA, Peterson D, Dunn J, Hambidge SJ, Dunstan M, Starkovich P, Yu O, Benoit J, Dominguez-Islas CP, Carste B, Benson P, Nelson JC - PLoS ONE (2011)

Bottom Line: 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).

View Article: PubMed Central - PubMed

Affiliation: Group Health Research Institute, Seattle, Washington, United States of America. Jackson.L@ghc.org

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).

Conclusion: The results of this relatively small trial suggest that acetaminophen may reduce the risk of post-vaccination fever and fussiness.

Trial registration: Clinicaltrials.gov NCT00325819.

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Related in: MedlinePlus

Distribution of participant age in weeks at the vaccination visit.
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pone-0020102-g002: Distribution of participant age in weeks at the vaccination visit.

Mentions: A total of 374 children were randomized and mailed the study product. Of those, 352, who were vaccinated between June 6, 2006 and September 28, 2009, received at least one dose of study medication and had a completed study diary returned (Figure 1). Those 352 children represent the intent to treat population assessed in the primary study analyses. The age range of those participants was 16 through 42 weeks with a bimodal distribution reflecting ages grouped around the times of the four and six month vaccinations (Figure 2). Other baseline characteristics are shown in Table 1. A subgroup of 234 children (124 acetaminophen and 110 placebo) met the per protocol definition.


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

Jackson LA, Peterson D, Dunn J, Hambidge SJ, Dunstan M, Starkovich P, Yu O, Benoit J, Dominguez-Islas CP, Carste B, Benson P, Nelson JC - PLoS ONE (2011)

Distribution of participant age in weeks at the vaccination visit.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3117800&req=5

pone-0020102-g002: Distribution of participant age in weeks at the vaccination visit.
Mentions: A total of 374 children were randomized and mailed the study product. Of those, 352, who were vaccinated between June 6, 2006 and September 28, 2009, received at least one dose of study medication and had a completed study diary returned (Figure 1). Those 352 children represent the intent to treat population assessed in the primary study analyses. The age range of those participants was 16 through 42 weeks with a bimodal distribution reflecting ages grouped around the times of the four and six month vaccinations (Figure 2). Other baseline characteristics are shown in Table 1. A subgroup of 234 children (124 acetaminophen and 110 placebo) met the per protocol definition.

Bottom Line: 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).

View Article: PubMed Central - PubMed

Affiliation: Group Health Research Institute, Seattle, Washington, United States of America. Jackson.L@ghc.org

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).

Conclusion: The results of this relatively small trial suggest that acetaminophen may reduce the risk of post-vaccination fever and fussiness.

Trial registration: Clinicaltrials.gov NCT00325819.

Show MeSH
Related in: MedlinePlus