ReviewPaediatric drugs2015
Ethics of drug research in the pediatric intensive care unit.
Review in Paediatric drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis 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
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.
- Human Ontogeny of Drug Transporters: Review and Recommendations of the Pediatric Transporter Working Group.Clinical pharmacology and therapeutics · 2015Pooled it
- Successful Use of [Clinical pharmacokinetics · 2017Trial
- A randomized controlled trial of daily sedation interruption in critically ill children.Intensive care medicine · 2016Trial
- Off-Label Medication Use in a Serbian Neonatal Intensive Care Unit: A Single-Center Retrospective Cohort Study.Journal of clinical medicine · 2026Article
- Research Ethics Challenges, Controversies and Difficulties in Intensive Care Units-A Systematic Review of Theoretical Concepts.Nursing reports (Pavia, Italy) · 2025Review
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study.Health technology assessment (Winchester, England) · 2023Article
- Deferred Consent in Neonatal Clinical Research: Why, When, How?Paediatric drugs · 2021Review
- Drug Utilisation and Off-Label Use on a German Neonatal Intensive Care Unit: A Retrospective Cohort Study and 10-Year Comparison.Pharmacy (Basel, Switzerland) · 2020Article
- Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.Clinical pharmacokinetics · 2019Review
- Patient and public involvement in Paediatric Intensive Care research: considerations, challenges and facilitating factors.Research involvement and engagement · 2016Review
- A Literature Review of the Pharmacokinetics and Pharmacodynamics of Dobutamine in Neonates.Pediatric cardiology · 2016Review
- Pain in Intellectually Disabled Children: Towards Evidence-Based Pharmacotherapy?Paediatric drugs · 2015Article
- Use of microdose phenotyping to individualise dosing of patients.Clinical pharmacokinetics · 2015Article
- Creating a new ethical climate for drug research in children and pregnant women.Paediatric drugs · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Critical illness and treatment modalities change pharmacokinetics and pharmacodynamics of medications used in critically ill children, in addition to age-related changes in drug disposition and effect. Hence, to ensure effective and safe drug therapy, research in this population is urgently needed. However, conducting research in the vulnerable population of the pediatric intensive care unit (PICU) presents with ethical challenges. This article addresses the main ethical issues specific to drug research in these critically ill children and proposes several solutions. The extraordinary environment of the PICU raises specific challenges to the design and conduct of research. The need for proxy consent of parents (or legal guardians) and the stress-inducing physical environment may threaten informed consent. The informed consent process is challenging because emergency research reduces or even eliminates the time to seek consent. Moreover, parental anxiety may impede adequate understanding and generate misconceptions. Alternative forms of consent have been developed taking into account the unpredictable reality of the acute critical care environment. As with any research in children, the burden and risk should be minimized. Recent developments in sample collection and analysis as well as pharmacokinetic analysis should be considered in the design of studies. Despite the difficulties inherent to drug research in critically ill children, methods are available to conduct ethically sound research resulting in relevant and generalizable data. This should motivate the PICU community to commit to drug research to ultimately provide the right drug at the right dose for every individual child.
Indexed as
Identifiers
What OpenQuestion holds
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.