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

Hand, Foot and Mouth Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241030
• Other study ID #: 2017-06-0024
• Status: Completed
• Phase: Phase 2
• Start date: September 12, 2017
• Est. completion date: June 20, 2019

Study information

• Verified date: October 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 20, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivostomatitis
• Hand, Foot and Mouth Disease
• Herpangina
• Mouth Diseases
• Oral Ulcer

Intervention

Drug:
• Sucralfate
Will receive 20mg/kg/dose up to 1 gram.

Other:
• Placebo
Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.

Drug:
• Acetaminophen
All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
• Ibuprofen
All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.

Locations

Country	Name	City	State
United States	Dell Children's Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Intake in ml/kg	Will quantify the amount (in ml/kg) of liquid ingested after intervention.	Approximately 60 minutes after medication administration.
Secondary	Number of Participants That Require Intravenous Fluid Administration	To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.	6 hours from the time of enrollment
Secondary	Number of Participants That Require Admission	To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.	6 hours from the time of enrollment
Secondary	Number of Participants With Unscheduled Visits	Will call families to find out about any unscheduled visits.	Approximately 72 hours from ED visit