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Trial record 2 of 2 for:    Recruiting, Not yet recruiting, Available Studies | "Laryngitis"

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

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ClinicalTrials.gov Identifier: NCT03705273
Recruitment Status : Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Donald H Arnold, Vanderbilt University Medical Center

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
Asthma Croup Drug: Dexamethasone IV for PO Drug: Dexamethasone crushed tablets Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 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
Estimated Study Start Date : October 22, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Dexamethasone oral tablet




Primary Outcome Measures :
  1. Taste [ Time Frame: 1 hour ]
    Child's reaction to taste of dexamethasone on 5-point smiley-face analog scale that measures taste. Total score will be a number from 1 to 5 (1 = strongly dislike, 5 = strongly like). A higher number is considered to be a better outcome.


Secondary Outcome Measures :
  1. Patients with nausea [ Time Frame: 1 hour ]
    Perceived nausea in the child after receiving dexamethasone; parents will be asked "did your child look like he/she wanted to throw up?"

  2. Reason for requiring a second dose of dexamethasone [ Time Frame: 1 hour ]
    Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705273


Contacts
Contact: Andrea Goettel, PharmD (615) 936-5495 Andrea.Goettel@vumc.org
Contact: Donald Arnold, MD, MPH (615) 936-4498 Don.Arnold@vumc.org

Locations
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Donald Arnold, MD, MPH Vanderbilt University Medical Center

Responsible Party: Donald H Arnold, Professor of Pediatrics, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03705273     History of Changes
Other Study ID Numbers: 181682
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Laryngitis
Asthma
Croup
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Laryngeal Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action