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Safety of ceftriaxone in paediatrics: a systematic review protocol

Linan Zeng1,2, Imti Choonara3, Lingli Zhang1,2

  • 1Department of Pharmacy, Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China.

BMJ Open
|August 23, 2017
PubMed

Insights

This review systematically evaluates ceftriaxone safety in pediatric sepsis treatment. It aims to identify adverse drug reactions (ADRs) across all pediatric age groups to inform clinical practice.

Area of Science:

  • Pediatric pharmacology
  • Infectious disease treatment
  • Drug safety and pharmacovigilance

Background:

  • Ceftriaxone is a common antibiotic for pediatric sepsis.
  • Concerns exist regarding ceftriaxone's safety, particularly in neonates and infants.
  • A comprehensive safety evaluation in children is warranted.

Purpose of the Study:

  • To systematically review the safety profile of ceftriaxone in pediatric patients.
  • To identify and quantify adverse drug reactions (ADRs) associated with ceftriaxone use in children.
  • To analyze safety data across different pediatric age groups and dosage regimens.

Main Methods:

  • Systematic literature search of multiple databases (MEDLINE, PubMed, EMBASE, etc.) and ADR monitoring systems.
  • Inclusion of various study designs: RCTs, cohort studies, case-control studies, case series, and case reports.
  • Quality assessment using Cochrane risk of bias, Newcastle-Ottawa, and NIH tools; meta-analysis of ADR incidence; subgroup analyses by age and dose.

Main Results:

  • Data synthesis on the incidence and types of adverse drug reactions (ADRs) associated with pediatric ceftriaxone use.
  • Identification of potential age-specific safety concerns or risk factors.
  • Quantitative assessment of ADRs through meta-analysis where data permit.

Conclusions:

  • Provide an evidence-based summary of ceftriaxone safety in pediatric populations.
  • Inform clinical guidelines and therapeutic decision-making for pediatric sepsis management.
  • Highlight areas for future research in pediatric antibiotic safety.
Abstract

Keywords:
CeftriaxonePaediatricsSafety

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