Can J Hosp Pharm. 2017 Jul-Aug;70(4):288-293. doi: 10.4212/cjhp.v70i4.1679. Epub 2017 Aug 31.
Need for a Randomized Controlled Trial of Stress Ulcer Prophylaxis in Critically Ill Children: A Canadian Survey.
The Canadian journal of hospital pharmacy
Mark Duffett, Karen Choong, Jennifer Foster, Elaine Gilfoyle, Jacques Lacroix, Deborah J Cook
Affiliations
Affiliations
- , PhD, RPh, is with the Department of Pediatrics, McMaster University, Hamilton, Ontario.
- MB, BCh, MSc, is with the Departments of Pediatrics and of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario.
- , MD, is with the Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia.
- , MD, MMEd, is with the Department of Paediatrics, University of Calgary, Calgary, Alberta.
- , MD, is with the Department of Pediatrics, Université de Montréal, Montréal, Quebec.
- , MD, MSc, is with the Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario.
PMID: 28894313
PMCID: PMC5587042 DOI: 10.4212/cjhp.v70i4.1679
Abstract
BACKGROUND: Stress ulcer prophylaxis is commonly used in pediatric critical care, to prevent upper gastrointestinal bleeding. The most frequently used agents are histamine-2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). The risk-benefit ratio for stress ulcer prophylaxis is uncertain, because data from randomized clinical trials (RCTs) on the effectiveness and harms of prophylaxis in children are limited.
OBJECTIVE: To describe the views of Canadian pediatric intensivists about a future RCT of stress ulcer prophylaxis.
METHODS: We conducted an online survey of Canadian pediatric critical care physicians. We e-mailed information about the study and a link to a 10-item survey to 111 potential respondents, with 2 reminders for nonrespondents. We assessed the relationship between respondents' characteristics and their views about the need for and potential participation in a trial using logistic regression and assessed regional differences using the χ
RESULTS: The 68 physicians who replied (61% of potential respondents) had a median of 12 (interquartile range 5-20) years of experience. Forty-four (65%) of the respondents stated that a large, rigorous RCT of stress ulcer prophylaxis in children is needed, and 94% (62 of 66) indicated that it should include a placebo group. The 3 most common designs suggested were a 3-arm trial comparing PPI, H2RA, and placebo (56% [37 of 66 respondents to this question]) and 2-arm trials comparing PPI with placebo (15% [
CONCLUSIONS: There is considerable interest in a placebo-controlled RCT of stress ulcer prophylaxis among pediatric critical care physicians in Canada, but consensus on key elements of the trial design is needed.
Keywords: essai clinique à répartition aléatoire; pediatric critical care; prophylaxie de l’ulcère de stress; randomized controlled trial; soins intensifs pédiatriques; sondage; stress ulcer prophylaxis; survey
Conflict of interest statement
Competing interests: None declared.
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