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Designing simple PK–PD studies in childrenALISON H. THOMSON MSc, PhD, MRPharmS1,2, HENRY L. ELLIOTT MD, FRCP3Article first published online: 29 OCT 2010DOI: 10.1111/j.1460-9592.2010.03436.x? 2010 Blackwell Publishing Ltd Issue
Pediatric AnesthesiaEarly View (Articles online in advance of print)Additional InformationHow to CiteTHOMSON, A. H. and ELLIOTT, H. L. , Designing simple PK–PD studies in children. Pediatric Anesthesia, no. doi: 10.1111/j.1460-9592.2010.03436.xAuthor Information1
Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde
2
Pharmacy and Prescribing Support Unit, Pharmacy Department, Western Infirmary
3
Education and Consulting, Anniesland, Glasgow, UK
*Correspondence: Alison H. Thomson, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G40RE, UK (email: alison.h.thomson@strath.ac.uk).Publication HistoryArticle first published online: 29 OCT 2010Accepted 26 August 2010 SEARCH Search Scope All contentPublication titlesIn this journalIn this issue Search String Advanced >Saved Searches > SEARCH BY CITATION Volume: Issue: Page: ARTICLE TOOLSGet PDF (134K)Save to My ProfileE-mail Link to this ArticleExport Citation for this ArticleRequest Permissions AbstractArticleReferencesCited By View Full Article (HTML) Get PDF (134K) Keywords:population approach;pediatrics;anesthetic agentsSummary
Conducting clinical pharmacology research studies in pediatric patients is challenging because of ethical and practical constraints but necessary to ensure that drugs are used safely and effectively in this population. Developments in laboratory analytical techniques, such as improved assay sensitivity and the use of alternative sample matrices, can reduce blood loss and offer less invasive blood sampling, causing less trauma to the patient and fewer ethical concerns. Recent advances in data analysis techniques, which aim to extract the maximum amount of useful information from small sample numbers, should be considered when planning a clinical trial and incorporated into the study design. Using ‘population’ methodology allows a more flexible sampling strategy that enables valuable data to be collected in the course of routine clinical practice, rather than in a rigid, and potentially artificial, setting. Integration of pharmacokinetics and pharmacodynamics and the application of physiological approaches and simulation techniques to the analysis and interpretation of drug concentration and effect data offer new opportunities that have particular relevance to pharmacological research in the field of pediatric anesthetics.
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Skip to main page content HOME CURRENT ISSUE PAST ISSUES CME SUBSCRIBE ONLINE HELP SUBMIT TO A&A ACTIVATE MY ACCOUNT Search GO Advanced Search ? User Name Password Sign In Postoperative Mortality in Children After 101,885 Anesthetics at a Tertiary Pediatric Hospital Benjamin F. van der Griend, MBBS, BMedSc, FANZCA*, Nichole A. Lister, BA, BSc(Hons), PhD?, Ian M. McKenzie, MBBS, DipRACOG, FANZCA?, Nick Martin, MBBS, FRCA, FANZCA?, Philip G. Ragg, MBBS, FFARACS, FANZCA?, Suzette J. Sheppard, BSc(Hons)? and Andrew J. Davidson, MBBS, MD, FANZCA? From *Christchurch Hospital, Christchurch, New Zealand and ? Royal Children's Hospital, University of Melbourne, Melbourne, Victoria, Australia. Address correspondence to Benjamin F. van der Griend, MBBS, BMedSc, FANZCA, Christchurch Hospital, Riccarton Avenue, Private Bag 4710, New Zealand. Address e-mail to ben{at}vandergriend.com. Abstract BACKGROUND: Mortality is a basic measure for quality and safety in anesthesia. There are few anesthesia-related mortality data available for pediatric practice. Our objective for this study was to determine the incidence of 24-hour and 30-day mortality after anesthesia and to determine the incidence and nature of anesthesia-related mortality in pediatric practice at a large tertiary institution. METHODS: Children ?18 years old who had an anesthetic between January 1, 2003, and August 30, 2008, at the Royal Children's Hospital, Melbourne, Australia, were included for this study. Data were analyzed by merging a database for every anesthetic performed with an accurate electronic record of mortality of children who had ever been a Royal Children's Hospital patient. Cases of children dying within 30 days and 24 hours of an anesthetic were identified and the patient history and anesthetic record examined. Anesthesia-related death was defined as those cases whereby a panel of 3 senior anesthesiologists all agreed that anesthesia or factors under the control of the anesthesiologist more likely than not influenced the timing of death. RESULTS: During this 68-month period, 101,885 anesthetics were administered to 56,263 children. The overall 24-hour mortality from any cause after anesthesia was 13.4 per 10,000 anesthetics delivered and 30-day mortality was 34.5 per 10,000 anesthetics delivered. The incidence of death was highest in children ?30 days old. Patients undergoing cardiac surgery had a higher incidence of 24-hour and 30-day mortality than did those undergoing noncardiac surgery. From 101,885 anesthetics there were 10 anesthesia-related deaths. The incidence of anesthesia-related death was 1 in 10,188 or 0.98 cases per 10,000 anesthetics performed (95%confidence interval, 0.5 to 1.8). In all 10 cases, preexisting medical conditions were identified as being a significant factor in the patient's death. Five of these cases (50%) involved children with pulmonary hypertension. CONCLUSIONS: Anesthesia-related mortality is higher in children with heart disease and in particular those with pulmonary hypertension. The lack of anesthetic-related deaths in children who did not have major comorbidities reinforces the safety of pediatric anesthesia in healthy children. Footnotes Funding: Hospital funded. The authors declare no conflicts of interest. Reprints will not be available from the authors. Accepted January 21, 2011. Copyright ? 2011 International Anesthesia Research Society ? Previous | Next Article ?Table of Contents This Article Published online before print May 4, 2011, doi: 10.1213/?ANE.0b013e318213be52 A & A June 2011 vol. 112 no. 6 1440-1447 ? Abstract Full Text Full Text (PDF) CME Classifications Pediatric Anesthesiology Services Email this article to a colleague Alert me when this article is cited Alert me if a correction is posted Similar articles in this journal Similar articles in PubMed Download to citation manager Request Permissions Citing Articles Load citing article information Google Scholar Articles by van der Griend, B. F. Articles by Davidson, A. J. PubMed PubMed citation Articles by van der Griend, B. F. Articles by Davidson, A. J. Related Content Outcomes Patient Safety Pediatrics Load related web page information Current Issue August 2011, 113 (2) 
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