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

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Herpangina; Gingivostomatitis; Hand, Foot and Mouth Disease

Treatments: Other: Placebo; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Sucralfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03241030

2017-06-0024

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

Subjects will receive sucralfate

Treatment:

Drug: Acetaminophen

Drug: Ibuprofen

Drug: Sucralfate

Placebo Group

Placebo Comparator group

Description:

Subjects will receive a placebo

Treatment:

Drug: Acetaminophen

Other: Placebo

Drug: Ibuprofen