Observational studyBMC medicine2013
Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children - a prospective observational cohort study of 6,601 admissions.
Observational study in BMC medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
53 citing papers in PubMed, 3 syntheses or guidelines pooled it, 103 citations in OpenAlex.
- Pharmacogenomic associations of adverse drug reactions in asthma: systematic review and research prioritisation.The pharmacogenomics journal · 2020Pooled it
- Mapping the prevalence and nature of drug related problems among hospitalised children in the United Kingdom: a systematic review.BMC pediatrics · 2019Pooled it
- Mortality among patients due to adverse drug reactions that occur following hospitalisation: a meta-analysis.European journal of clinical pharmacology · 2019Pooled it
- A pilot randomised controlled trial to assess the utility of an e-learning package that trains users in adverse drug reaction causality.The International journal of pharmacy practice · 2015Trial
- Genetic PolymorphismsPharmaceuticals (Basel, Switzerland) · 2026Article
- Polypharmacy and adverse drug reactions among hospitalised children: determinants and clinical and economic impact in a multicentre prospective cohort and nested matched case-control study in Northwest Ethiopia.BMJ paediatrics open · 2026Article
- Sertraline safety in adolescents experiencing a depressive episode during first 3 weeks: added anxiolytic matters more than CYP2C19 polymorphisms.Frontiers in pharmacology · 2026Article
- Pediatric Pharmacy Association 2025 KIDs List of Key Potentially Inappropriate Drugs in Pediatrics.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- Moving Away from One-Size-Fits-All: Assessing the Use of Pharmacogenetic-Guided Medication Therapy in Pediatric Patients with Chronic Pain.Children (Basel, Switzerland) · 2025Article
- Prevalence of key potentially inappropriate drugs use in pediatrics: a cross-sectional study.BMC pediatrics · 2024Observational
- Adverse drug reactions in paediatric surgery: prospective study on frequency and risk related factors.BMC pediatrics · 2024Observational
- Risk Factors Associated With Drug-Related Side Effects in Children: A Scoping Review.Global pediatric health · 2024Article
- Observational
- Causality, Severity, and Avoidability of Adverse Drug Reactions in Hospitalized Children: A Prospective Cohort Study.Cureus · 2023Article
- Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature.Therapeutic advances in drug safety · 2023Review
- The evaluation of adverse drug reactions in Saudi Arabia: A retrospective observational study.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022Article
- Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs.International journal of environmental research and public health · 2022Article
- The Impact of Clinical Pharmacy Services in a Tertiary Care Center Specialized in Pediatric Hemato-Oncology.Children (Basel, Switzerland) · 2022Article
- Implementing a specialist paediatric clinical pharmacology service in a UK children's hospital.British journal of clinical pharmacology · 2022Article
- Causality and avoidability of adverse drug reactions of antibiotics in hospitalized children: a cohort study.International journal of clinical pharmacy · 2021Article
Corrections and comments
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Authors and funding
15 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundAdverse drug reactions (ADRs) are an important cause of harm in children. Current data are incomplete due to methodological differences between studies: only half of all studies provide drug data, incidence rates vary (0.6% to 16.8%) and very few studies provide data on causality, severity and risk factors of pediatric ADRs. We aimed to determine the incidence of ADRs in hospitalized children, to characterize these ADRs in terms of type, drug etiology, causality and severity and to identify risk factors.
methodsWe undertook a year-long, prospective observational cohort study of admissions to a single UK pediatric medical and surgical secondary and tertiary referral center (Alder Hey, Liverpool, UK). Children between 0 and 16 years 11 months old and admitted for more than 48 hours were included. Observed outcomes were occurrence of ADR and time to first ADR for the risk factor analysis.
resultsA total of 5,118 children (6,601 admissions) were included, 17.7% of whom experienced at least one ADR. Opiate analgesics and drugs used in general anesthesia (GA) accounted for more than 50% of all drugs implicated in ADRs. Of these ADRs, 0.9% caused permanent harm or required admission to a higher level of care. Children who underwent GA were at more than six times the risk of developing an ADR than children without a GA (hazard ratio (HR) 6.40; 95% confidence interval (CI) 5.30 to 7.70). Other factors increasing the risk of an ADR were increasing age (HR 1.06 for each year; 95% CI 1.04 to 1.07), increasing number of drugs (HR 1.25 for each additional drug; 95% CI 1.22 to 1.28) and oncological treatment (HR 1.90; 95% CI 1.40 to 2.60).
conclusionsADRs are common in hospitalized children and children who had undergone a GA had more than six times the risk of developing an ADR. GA agents and opiate analgesics are a significant cause of ADRs and have been underrepresented in previous studies. This is a concern in view of the increasing number of pediatric short-stay surgeries.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.