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Can J Hosp Pharm. 2017 Jul-Aug;70(4):288-293. Epub 2017 Aug 31.

Need for a Randomized Controlled Trial of Stress Ulcer Prophylaxis in Critically Ill Children: A Canadian Survey.

Author information

1
, PhD, RPh, is with the Department of Pediatrics, McMaster University, Hamilton, Ontario.
2
MB, BCh, MSc, is with the Departments of Pediatrics and of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario.
3
, MD, is with the Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia.
4
, MD, MMEd, is with the Department of Paediatrics, University of Calgary, Calgary, Alberta.
5
, MD, is with the Department of Pediatrics, Université de Montréal, Montréal, Quebec.
6
, MD, MSc, is with the Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario.

Abstract

in English, French

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 χ2 test.

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% [n = 10]) and H2RA with placebo (8% [n = 5]). The 5 patient groups that respondents most commonly stated should be excluded (because they should not receive placebo) were children receiving acid suppression at home (66% [42 of 64 respondents to this question]) or corticosteroids (59% [n = 38]), those with severe coagulopathy or receiving extracorporeal membrane oxygenation (both 36% [n = 23]), and those with burns (31% [n = 20]). Most respondents indicated a willingness to participate in an RCT (64% [42 of 66 respondents to this question]), whereas some (29% [n = 19]) indicated that participation would depend on trial design or funding; only 8% (n = 5) were disinclined to participate.

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

PMID:
28894313
PMCID:
PMC5587042

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