Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Primary Purpose
Herpangina, Gingivostomatitis, Hand, Foot and Mouth Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sucralfate
Placebo
Acetaminophen
Ibuprofen
Sponsored by
About this trial
This is an interventional supportive care trial for Herpangina
Eligibility 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
Sites / Locations
- Dell Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Group
Placebo Group
Arm Description
Subjects will receive sucralfate
Subjects will receive a placebo
Outcomes
Primary Outcome Measures
Oral Intake in ml/kg
Will quantify the amount (in ml/kg) of liquid ingested after intervention.
Secondary Outcome Measures
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.
Number of Participants That Require Admission
To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.
Number of Participants With Unscheduled Visits
Will call families to find out about any unscheduled visits.
Full Information
NCT ID
NCT03241030
First Posted
July 28, 2017
Last Updated
October 26, 2021
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT03241030
Brief Title
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Official Title
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
June 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpangina, Gingivostomatitis, Hand, Foot and Mouth Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Subjects will receive sucralfate
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects will receive a placebo
Intervention Type
Drug
Intervention Name(s)
Sucralfate
Intervention Description
Will receive 20mg/kg/dose up to 1 gram.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oral Intake in ml/kg
Description
Will quantify the amount (in ml/kg) of liquid ingested after intervention.
Time Frame
Approximately 60 minutes after medication administration.
Secondary Outcome Measure Information:
Title
Number of Participants That Require Intravenous Fluid Administration
Description
To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.
Time Frame
6 hours from the time of enrollment
Title
Number of Participants That Require Admission
Description
To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.
Time Frame
6 hours from the time of enrollment
Title
Number of Participants With Unscheduled Visits
Description
Will call families to find out about any unscheduled visits.
Time Frame
Approximately 72 hours from ED visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Vaidya, MD
Organizational Affiliation
UT Dell Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dell Children's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33867179
Citation
Singh NV, Gabriele GA, Wilkinson MH. Sucralfate as an Adjunct to Analgesia to Improve Oral Intake in Children With Infectious Oral Ulcers: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Emerg Med. 2021 Sep;78(3):331-339. doi: 10.1016/j.annemergmed.2021.01.019. Epub 2021 Apr 16.
Results Reference
derived
Learn more about this trial
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
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