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Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT03705273
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
23.3
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone IV for PO
  • Drug: Dexamethasone crushed tablets
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup
Actual Study Start Date :
Oct 23, 2018
Actual Primary Completion Date :
Oct 2, 2020
Actual Study Completion Date :
Oct 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexamethasone IV for PO

Dexamethasone IV for PO solution mixed with sugar syrup to be given orally

Drug: Dexamethasone IV for PO
Common pediatric emergency department practice
Other Names:
  • Dexamethasone injection

    		•
    Active Comparator: Dexamethasone crushed tablets

    Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally

    Drug: Dexamethasone crushed tablets
    Alternative route of administration for patients unable to swallow tablet whole
    Other Names:
  • Dexamethasone oral tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Nausea [1 hour]

      Presence of nausea after medication administration (yes/no) measured by participant self-report

    Secondary Outcome Measures

    1. Number of Participants Requiring Second Dose of Dexamethasone [1 hour]

      Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt Children's Hospital Emergency Department

    • Age 1 to 7 years

    • Dexamethasone treatment indicated

    • No other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis)

    • Have not received systemic corticosteroid for current episode prior to enrollment

    Exclusion Criteria:

    • Allergy to dexamethasone or apple sauce and pudding

    • Unable to take medication orally

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

    Sponsors and Collaborators

    • Vanderbilt University Medical Center

    Investigators

    • Principal Investigator: Donald Arnold, MD, MPH, Vanderbilt University Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Donald H Arnold, Professor of Pediatrics, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03705273
    Other Study ID Numbers:
    • 181682
    First Posted:
    Oct 15, 2018
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Asthma
    Croup
    Dexamethasone
    Dexamethasone acetate
    BB 1101

    Study Results

    Participant Flow

    Recruitment Details Forty participants were enrolled and randomized, of which 20 were randomized to receive dexamethasone tablets.
    Pre-assignment Detail
    Arm/Group Title Dexamethasone Tablets Dexamethasone-IV Solution-in-syrup
    Arm/Group Description Dexamethasone tablets crushed and administered in apple sauce or pudding at a dose of 0.6 mg/kg Dexamethasone-IV solution-in-syrup at a dose of 0.6 mg/kg
    Period Title: Overall Study
    STARTED 20 20
    COMPLETED 20 20
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Dexamethasone IV for PO Dexamethasone Crushed Tablets Total
    Arm/Group Description Dexamethasone IV for PO solution mixed with sugar syrup to be given orally Dexamethasone IV for PO: Common pediatric emergency department practice Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally or dexamethasone IV solution in cherry syrup Total of all reporting groups
    Overall Participants 20 20 40
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    2.75
    (1.88)
    2.70
    (1.92)
    2.75
    (1.88)
    Sex: Female, Male (Count of Participants)
    Female
    7
    35%
    12
    60%
    19
    47.5%
    Male
    13
    65%
    8
    40%
    21
    52.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    15
    75%
    15
    75%
    30
    75%
    White
    5
    25%
    5
    25%
    10
    25%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    20
    100%
    20
    100%
    40
    100%
    Diagnosis asthma (Count of Participants)
    Count of Participants [Participants]
    15
    75%
    16
    80%
    31
    77.5%
    Diagnosis croup (Count of Participants)
    Count of Participants [Participants]
    5
    25%
    4
    20%
    9
    22.5%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Nausea
    Description Presence of nausea after medication administration (yes/no) measured by participant self-report
    Time Frame 1 hour

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Dexamethasone Tablets Dexamethasone IV for PO
    Arm/Group Description Dexamethasone tablets crushed and mixed in apple sauce Dexamethasone IV solution mixed with cherry syrup
    Measure Participants 20 20
    Count of Participants [Participants]
    3
    15%
    0
    0%
    2. Secondary Outcome
    Title Number of Participants Requiring Second Dose of Dexamethasone
    Description Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose
    Time Frame 1 hour

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Dexamethasone Tablets Dexamethasone IV for PO
    Arm/Group Description Dexamethasone tablets crushed and mixed in apple sauce Dexamethasone IV solution mixed with cherry syrup
    Measure Participants 20 20
    Count of Participants [Participants]
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Time of randomization up to one hour after last dose of treatment
    Adverse Event Reporting Description Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
    Arm/Group Title Dexamethasone IV for PO Dexamethasone Crushed Tablets
    Arm/Group Description Dexamethasone IV for PO solution mixed with sugar syrup to be given orally Dexamethasone IV for PO: Common pediatric emergency department practice Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally Dexamethasone crushed tablets: Alternative route of administration for patients unable to swallow tablet whole
    All Cause Mortality
    Dexamethasone IV for PO Dexamethasone Crushed Tablets
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/20 (0%) 0/20 (0%)
    Serious Adverse Events
    Dexamethasone IV for PO Dexamethasone Crushed Tablets
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/20 (0%) 0/20 (0%)
    Other (Not Including Serious) Adverse Events
    Dexamethasone IV for PO Dexamethasone Crushed Tablets
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/20 (0%) 0/20 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Donald H. Arnold, MD, MPH
    Organization Vanderbilt University School of Medicine
    Phone 16155790516
    Email don.arnold@vumc.org
    Responsible Party:
    Donald H Arnold, Professor of Pediatrics, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03705273
    Other Study ID Numbers:
    • 181682
    First Posted:
    Oct 15, 2018
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Oct 1, 2021