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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
102
Will receive 20mg/kg/dose up to 1 gram.
Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.
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.
Dell Children's Medical Center
Austin, Texas, United States
Oral Intake in ml/kg
Will quantify the amount (in ml/kg) of liquid ingested after intervention.
Time frame: Approximately 60 minutes after medication administration.
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.
Time frame: 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.
Time frame: 6 hours from the time of enrollment
Number of Participants With Unscheduled Visits
Will call families to find out about any unscheduled visits.
Time frame: Approximately 72 hours from ED visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.