• Nidhi V Singh, Giovanni A Gabriele, and Matthew H Wilkinson.
• Department of Pediatric Emergency Medicine, Baylor College of Medicine, Houston, TX. Electronic address: nvsingh@bcm.edu.
• Ann Emerg Med. 2021 Sep 1; 78 (3): 331-339.

Study HypothesisWe hypothesized that sucralfate along with oral analgesics (acetaminophen or ibuprofen) administered in the emergency department leads to a clinically significant improvement in oral intake in children with acute infectious oral ulcers.MethodsThis was a randomized, double-blind, placebo-controlled trial of sucralfate versus placebo conducted between 2017 and 2018 in an urban pediatric emergency department. Children aged 6 months to 5 years with acute, infectious oral ulcers and poor oral intake received either acetaminophen at 15 mg/kg or ibuprofen at 10 mg/kg and were then randomized to receive sucralfate at 20 mg/kg per dose up to 1 g or a placebo solution. The primary outcome was oral fluid intake within 60 minutes of medication administration. The secondary outcomes were repeat ED visits, length of stay in ED, intravenous hydration rate, admission rate, adverse event rate, and emergency physician's determination of the adequacy of oral intake.ResultsOne hundred subjects with mild dehydration (clinical dehydration score of 1) and a median age of 1.38 years were enrolled and analyzed (49 in the sucralfate group and 51 in the placebo group). Oral intake 1 hour after drug administration was similar in both the groups: the median intake in the sucralfate group was 9.7 mL/kg and 10.7 mL/kg in the placebo group (difference -1 mL/kg; 95% confidence interval [CI] -2.0 to 4.8). According to the emergency physician's report, the secondary outcomes were significant only for adequate oral intake: 71% in the sucralfate group versus 88% in the placebo group (difference -16.8%; 95% CI -32.2 to -1.4).ConclusionSucralfate as an adjunct to oral analgesics was not superior to placebo in improving oral intake in children with acute oral infectious ulcers.Copyright © 2021 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

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