Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
NCT ID: NCT03241030
Last Updated: 2021-10-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2017-09-12
2019-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Experimental Group
Subjects will receive sucralfate
Sucralfate
Will receive 20mg/kg/dose up to 1 gram.
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.
Placebo Group
Subjects will receive a placebo
Placebo
Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.
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.
Interventions
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Sucralfate
Will receive 20mg/kg/dose up to 1 gram.
Placebo
Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
5 Years
ALL
No
Sponsors
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University of Texas at Austin
OTHER
Responsible Party
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Nidhi Vaidya
Resident
Principal Investigators
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Nina Vaidya, MD
Role: PRINCIPAL_INVESTIGATOR
UT Dell Medical School
Locations
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Dell Children's Medical Center
Austin, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-06-0024
Identifier Type: -
Identifier Source: org_study_id