Status:
COMPLETED
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Lead Sponsor:
University of Texas at Austin
Conditions:
Herpangina
Gingivostomatitis
Eligibility:
All Genders
6-5 years
Phase:
PHASE2
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 thei...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03241030
Start Date
September 12 2017
End Date
June 20 2019
Last Update
October 29 2021
Active Locations (1)
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1
Dell Children's Medical Center
Austin, Texas, United States, 78723