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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Herpangina, Gingivostomatitis, Hand, Foot and Mouth Disease

Intervention / Treatment
-----------------
* Drug: Sucralfate
* Other: Placebo
* Drug: Acetaminophen
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Subjects will receive sucralfate | Drug: Sucralfate<br>* Will receive 20mg/kg/dose up to 1 gram.<br>Drug: Acetaminophen<br>* 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.<br>Drug: Ibuprofen<br>* 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.<br>|
| Placebo Comparator: Placebo Group<br>Subjects will receive a placebo | Other: Placebo<br>* Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.<br>Drug: Acetaminophen<br>* 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.<br>Drug: Ibuprofen<br>* 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.<br>|

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 |