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An assessment of the safety of pediatric ibuprofen. A practitioner-based randomized clinical trial

S M Lesko1, A A Mitchell

  • 1Slone Epidemiology Unit, School of Public Health, Boston University School of Medicine, Brookline, MA 02146.

JAMA
|March 22, 1995
PubMed

Insights

Short-term ibuprofen use in children did not increase hospitalizations for gastrointestinal bleeding, renal failure, or anaphylaxis. This study focused on specific severe outcomes, not less severe events or prolonged use.

Area of Science:

  • Pediatric pharmacology
  • Clinical research
  • Drug safety

Background:

  • Fever is common in children, often treated with antipyretics like ibuprofen and acetaminophen.
  • Concerns exist regarding potential severe adverse events associated with ibuprofen in pediatric populations.
  • Understanding the comparative safety profiles of common antipyretics is crucial for clinical practice.

Purpose of the Study:

  • To evaluate whether ibuprofen increases the risk of hospitalization for specific serious adverse events in febrile children.
  • To compare the safety of ibuprofen versus acetaminophen in a large pediatric cohort.
  • To investigate hospitalizations for gastrointestinal bleeding, renal failure, and anaphylaxis.

Main Methods:

  • A randomized, double-blind, acetaminophen-controlled trial was conducted in outpatient pediatric and family medicine settings.
  • 84,192 febrile children were randomized to receive acetaminophen or one of two ibuprofen dosages.
  • Primary outcomes included hospitalizations for acute gastrointestinal bleeding, acute renal failure, and anaphylaxis.

Main Results:

  • Hospitalization rates did not differ between ibuprofen and acetaminophen groups.
  • Four cases of nonmajor gastrointestinal bleeding occurred, with no significant difference in risk between ibuprofen and acetaminophen.
  • No hospitalizations for acute renal failure or anaphylaxis were observed; risk estimates were low for ibuprofen-treated children.

Conclusions:

  • Short-term ibuprofen use in children is not associated with an increased risk of hospitalization for gastrointestinal bleeding, renal failure, or anaphylaxis.
  • The study provides evidence for the safety of ibuprofen concerning these specific severe outcomes.
  • Data do not extend to less severe outcomes or risks associated with prolonged ibuprofen use.
Abstract

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