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