{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T06:11:02Z","timestamp":1791267062785,"version":"4.1.0"},"reference-count":11,"publisher":"American Academy of Pediatrics (AAP)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[1999,10,1]]},"abstract":"<jats:sec>\n                  <jats:title>Background.<\/jats:title>\n                  <jats:p>Recently ibuprofen has been introduced as a nonprescription analgesic\/antipyretic for use in children.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective.<\/jats:title>\n                  <jats:p>To compare the incidence of serious adverse clinical events among children &amp;lt;2 years old given ibuprofen and acetaminophen to control fever.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Study Design.<\/jats:title>\n                  <jats:p>A practitioner-based, randomized clinical trial. A total of 27\u2009065 febrile children were randomized to receive acetaminophen (12 mg\/kg), ibuprofen (5 mg\/kg), or ibuprofen (10 mg\/kg). Rates of hospitalization for acute gastrointestinal bleeding, acute renal failure, anaphylaxis, Reye's syndrome, asthma, bronchiolitis, and vomiting\/gastritis were compared by randomization group.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results.<\/jats:title>\n                  <jats:p>The risk of hospitalization with any diagnosis in the 4 weeks after enrollment was 1.4% (95% confidence interval, 1.3%\u20131.6%) and did not vary by antipyretic assignment. No children were hospitalized for acute renal failure, anaphylaxis, or Reye's syndrome. Three children were hospitalized with gastrointestinal bleeding; all 3 had been assigned to treatment with ibuprofen. The risk of hospitalization with gastrointestinal bleeding among children randomized to ibuprofen was 17 per 100\u2009000 (95% confidence interval, 3.5\u201349 per 100\u2009000) but was not significantly greater than the risk among children given acetaminophen. The risk of hospitalization with asthma, bronchiolitis, or vomiting\/gastritis did not differ by antipyretic assignment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions.<\/jats:title>\n                  <jats:p>The risk of serious adverse clinical events among children &amp;lt;2 years old receiving short-term treatment with either acetaminophen or ibuprofen suspension was small and did not vary by choice of medication. These data do not provide any information on the safety of these medications when used for prolonged periods or when used together, regardless of duration.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1542\/peds.104.4.e39","type":"journal-article","created":{"date-parts":[[2004,8,13]],"date-time":"2004-08-13T23:45:45Z","timestamp":1092440745000},"page":"e39-e39","source":"Crossref","is-referenced-by-count":166,"title":["The Safety of Acetaminophen and Ibuprofen Among Children Younger Than Two Years Old"],"prefix":"10.1542","volume":"104","author":[{"given":"Samuel M.","family":"Lesko","sequence":"first","affiliation":[{"name":"1From the Slone Epidemiology Unit, Boston University School of Medicine, Brookline, Massachusetts."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allen A.","family":"Mitchell","sequence":"additional","affiliation":[{"name":"1From the Slone Epidemiology Unit, Boston University School of Medicine, Brookline, Massachusetts."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[1999,10,1]]},"reference":[{"key":"2021121002551171200_B1","doi-asserted-by":"crossref","first-page":"929","DOI":"10.1001\/jama.1995.03520360043037","article-title":"An assessment of the safety of pediatric ibuprofen: a practitioner-based randomized clinical trial.","volume":"273","author":"Lesko","year":"1995","journal-title":"JAMA."},{"key":"2021121002551171200_B2","doi-asserted-by":"crossref","first-page":"986","DOI":"10.1001\/jama.1996.03530370024017","article-title":"Pediatric ibuprofen and leukopenia.","volume":"275","author":"Lesko","year":"1996","journal-title":"JAMA."},{"key":"2021121002551171200_B3","doi-asserted-by":"crossref","first-page":"954","DOI":"10.1542\/peds.100.6.954","article-title":"Renal function following short-term ibuprofen use in infants and children.","volume":"100","author":"Lesko","year":"1997","journal-title":"Pediatrics."},{"key":"2021121002551171200_B4","doi-asserted-by":"crossref","first-page":"15","DOI":"10.2165\/00002018-199513010-00003","article-title":"When a randomized controlled trial is needed to assess drug safety: the case of pediatric ibuprofen.","volume":"13","author":"Mitchell","year":"1995","journal-title":"Drug Saf."},{"key":"2021121002551171200_B5"},{"key":"2021121002551171200_B6"},{"key":"2021121002551171200_B7","doi-asserted-by":"crossref","first-page":"607","DOI":"10.1093\/ajcn\/32.3.607","article-title":"Physical growth: National Center for Health Statistics percentiles.","volume":"32","author":"Hamill","year":"1979","journal-title":"Am J Clin Nutr."},{"key":"2021121002551171200_B8","first-page":"726","article-title":"Asthma hospitalizations and readmissions among children and young adults\u2014Wisconsin, 1991\u20131995.","volume":"46","author":"Goldring","year":"1997","journal-title":"MMWR. 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