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Prospective observational study of adverse drug reactions to diclofenac in children

Joseph F Standing1, Kuan Ooi, Simon Keady

  • 1Great Ormond Street Hospital for Children, School of Pharmacy, University of London, London, UK. joseph.standing@farmbio.uu.se

British Journal of Clinical Pharmacology
|August 22, 2009
PubMed

Insights

Diclofenac in children for acute pain caused non-serious adverse reactions similar to adults, with a serious adverse reaction incidence below 0.8%. This study analyzed diclofenac utilization and adverse events in pediatric patients.

Area of Science:

  • Pediatric Pharmacology
  • Clinical Drug Safety
  • Pain Management

Background:

  • Diclofenac is commonly used for acute pain in children.
  • Understanding its adverse reaction profile in pediatric populations is crucial for safe clinical practice.

Purpose of the Study:

  • To investigate the types of common adverse reactions (>1% incidence) associated with diclofenac use in children under 12 years old for acute pain.
  • To assess the incidence of serious adverse reactions to diclofenac in this pediatric cohort.

Main Methods:

  • A prospective observational study was conducted on pediatric surgical patients (age ≤12 years).
  • Adverse events were systematically recorded, and causality was assessed for diclofenac-related events.
  • A subset of patients received diclofenac, allowing for utilization analysis. Serious adverse events were reviewed by an expert panel.

Main Results:

  • Data from 380 children indicated that non-serious adverse reactions were similar to those observed in adults.
  • Commonly reported non-serious reactions included rash (0.8%), minor central nervous system disturbance (0.5%), rectal irritation (0.3%), and diarrhea (0.3%).
  • No serious adverse events were attributed to diclofenac, establishing an upper incidence limit of <0.8% for serious reactions.

Conclusions:

  • Diclofenac administered to children for acute pain presents a similar adverse reaction profile to that seen in adults.
  • The incidence of serious adverse reactions in children treated with diclofenac is less than 0.8%.
Abstract

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