Hand, Foot and Mouth Disease Clinical Trial
Official title:
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Verified date | October 2021 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | June 20, 2019 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 5 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dell Children's Medical Center | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oral Intake in ml/kg | Will quantify the amount (in ml/kg) of liquid ingested after intervention. | Approximately 60 minutes after medication administration. | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Number of Participants With Unscheduled Visits | Will call families to find out about any unscheduled visits. | Approximately 72 hours from ED visit |
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