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Completed

NCT Number: NCT03241030

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.

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Key information

Conditions

Herpangina Coxsackievirus Infections Echovirus Infections Enterovirus Infections Gingivostomatitis Hand, Foot and Mouth Disease Infections Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dell Children's Medical Center

Austin, Texas, 78723, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sucralfate

Drug

Will receive 20mg/kg/dose up to 1 gram.

Placebo

Other

Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.

Acetaminophen

Drug

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.

Ibuprofen

Drug

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.

Primary outcomes

  1. Oral Intake in ml/kg

    Time frame: Approximately 60 minutes after medication administration.

    Will quantify the amount (in ml/kg) of liquid ingested after intervention.

Secondary outcomes

  1. Number of Participants That Require Intravenous Fluid Administration

    Time frame: 6 hours from the time of enrollment

    To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.

  2. Number of Participants That Require Admission

    Time frame: 6 hours from the time of enrollment

    To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.

  3. Number of Participants With Unscheduled Visits

    Time frame: Approximately 72 hours from ED visit

    Will call families to find out about any unscheduled visits.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 7, 2017
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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