Herpangina, Gingivostomatitis, Hand, Foot and Mouth Disease
Conditions
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.
Interventions
DRUGSucralfate
Will receive 20mg/kg/dose up to 1 gram.
OTHERPlacebo
Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.
DRUGAcetaminophen
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.
DRUGIbuprofen
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.
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Intake in ml/kg | Approximately 60 minutes after medication administration. | Will quantify the amount (in ml/kg) of liquid ingested after intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| 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. | 51 |
| Total | 100 |
Baseline characteristics
| Characteristic | Experimental Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 49 Participants | 51 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American/Black | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 39 Participants | 42 Participants | 81 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Female | 25 Participants | 28 Participants | 53 Participants |
| Sex: Female, Male Male | 24 Participants | 23 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 51 |
| other Total, other adverse events | 0 / 49 | 0 / 51 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 |
Outcome results
Primary
Oral Intake in ml/kg
Will quantify the amount (in ml/kg) of liquid ingested after intervention.
Time frame: Approximately 60 minutes after medication administration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental Group | Oral Intake in ml/kg | 9.7 oral intake in ml/kg |
| Placebo Group | Oral Intake in ml/kg | 10.7 oral intake in ml/kg |
Secondary
Number of Participants That Require Admission
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group | Number of Participants That Require Admission | 1 Participants |
| Placebo Group | Number of Participants That Require Admission | 2 Participants |
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.
Time frame: 6 hours from the time of enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group | Number of Participants That Require Intravenous Fluid Administration | 5 Participants |
| Placebo Group | Number of Participants That Require Intravenous Fluid Administration | 1 Participants |
Secondary
Number of Participants With Unscheduled Visits
Will call families to find out about any unscheduled visits.
Time frame: Approximately 72 hours from ED visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group | Number of Participants With Unscheduled Visits | 4 Participants |
| Placebo Group | Number of Participants With Unscheduled Visits | 6 Participants |