Overview

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

Status:
Completed
Trial end date:
2019-06-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Texas at Austin
Treatments:
Acetaminophen
Ibuprofen
Sucralfate
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