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

PHASE2CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

September 12, 2017

Primary Completion Date

July 31, 2018

Study Completion Date

June 20, 2019

Conditions
HerpanginaGingivostomatitisHand, Foot and Mouth Disease
Interventions
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.

DRUG

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.

Trial Locations (1)

78723

Dell Children's Medical Center, Austin

All Listed Sponsors
lead

University of Texas at Austin

OTHER

NCT03241030 - Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial | Biotech Hunter | Biotech Hunter