Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial

The purpose of this study is to see if sucralfate, a medication commonly used for patients with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level and improve their ability to drink.

Study Overview

• Status: Completed
• Conditions: Hand, Foot and Mouth Disease; Herpangina; Gingivostomatitis
• Intervention / Treatment: Drug: Sucralfate; Drug: Acetaminophen; Drug: Ibuprofen; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥6 months and ≤5 years old
• Present with oral infectious ulcers such as gingivostomatitis, herpangina, or hand, foot and mouth disease
• History of decreased oral fluid intake by parent or guardian
• English or Spanish speaking parents or guardians

Exclusion Criteria:

• Severely dehydrated or toxic, requiring immediate resuscitation
• Exclusively breastfed
• Severe dental disease
• Significant mouth trauma
• Active Malignancy
• Preexisting upper airway obstruction or swallowing difficulties
• Received intravenous fluids within 24 hours
• Administration of BOTH acetaminophen AND ibuprofen prior to triage and within 4 hours of enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Subjects will receive sucralfate	Drug: Sucralfate; Will receive 20mg/kg/dose up to 1 gram.; Drug: Acetaminophen; All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.; Drug: Ibuprofen; All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
Placebo Comparator: Placebo Group; Subjects will receive a placebo	Drug: Acetaminophen; All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.; Drug: Ibuprofen; All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.; Other: Placebo; Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Intake in ml/kg	Will quantify the amount (in ml/kg) of liquid ingested after intervention.	Approximately 60 minutes after medication administration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Require Intravenous Fluid Administration	To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.	6 hours from the time of enrollment
Number of Participants That Require Admission	To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.	6 hours from the time of enrollment
Number of Participants With Unscheduled Visits	Will call families to find out about any unscheduled visits.	Approximately 72 hours from ED visit

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Nina Vaidya, MD, UT Dell Medical School

Publications and helpful links

General Publications

• Singh NV, Gabriele GA, Wilkinson MH. Sucralfate as an Adjunct to Analgesia to Improve Oral Intake in Children With Infectious Oral Ulcers: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Emerg Med. 2021 Sep;78(3):331-339. doi: 10.1016/j.annemergmed.2021.01.019. Epub 2021 Apr 16.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Enterovirus Infections; Picornaviridae Infections; Coxsackievirus Infections; Echovirus Infections; Mouth Diseases; Oral Ulcer; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Herpangina; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Gastrointestinal Agents; Anti-Ulcer Agents; Acetaminophen; Ibuprofen; Sucralfate
• Other Study ID Numbers: 2017-06-0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No