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

Phase 2

Completed

• Conditions: Hand, Foot and Mouth Disease; Herpangina; Gingivostomatitis
• Interventions: Drug: Sucralfate; Other: Placebo; Drug: Acetaminophen; Drug: Ibuprofen

• Registration Number: NCT03241030
• Lead Sponsor: University of Texas at Austin

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 their ability to drink.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-07
• Study Start: 2017-09-12
• Primary Completion: 2018-07-31
• Study Completion: 2019-06-20
• Results First Submitted: 2021-05-17
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-26
• Last Update Submitted: 2021-10-26
• Results First Posted: 2021-10-29
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Sucralfate	Subjects will receive sucralfate
Experimental Group	Acetaminophen	Subjects will receive sucralfate
Placebo Group	Placebo	Subjects will receive a placebo
Experimental Group	Ibuprofen	Subjects will receive sucralfate
Placebo Group	Acetaminophen	Subjects will receive a placebo
Placebo Group	Ibuprofen	Subjects will receive a placebo

Primary Outcome Measures

Name	Time	Method
Oral Intake in ml/kg	Approximately 60 minutes after medication administration.	Will quantify the amount (in ml/kg) of liquid ingested after intervention.

Secondary Outcome Measures

Name	Time	Method
Number of Participants That Require Intravenous Fluid Administration	6 hours from the time of enrollment	To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.
Number of Participants That Require Admission	6 hours from the time of enrollment	To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.
Number of Participants With Unscheduled Visits	Approximately 72 hours from ED visit	Will call families to find out about any unscheduled visits.

Trial Locations

Locations (1)

Dell Children's Medical Center; 🇺🇸 Austin, Texas, United States