NCT03705273

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

October 23, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 8, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

October 9, 2018

Results QC Date

September 13, 2021

Last Update Submit

October 11, 2021

Conditions

AsthmaCroup

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Nausea

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

    1 hour

Secondary Outcomes (1)

  • Number of Participants Requiring Second Dose of Dexamethasone

    1 hour

Study Arms (2)

Dexamethasone IV for PO

EXPERIMENTAL

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

Drug: Dexamethasone IV for PO

Dexamethasone crushed tablets

ACTIVE COMPARATOR

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

Drug: Dexamethasone crushed tablets

Interventions

Dexamethasone IV for PODRUG

Common pediatric emergency department practice

Also known as: Dexamethasone injection
Dexamethasone IV for PO
Dexamethasone crushed tabletsDRUG

Alternative route of administration for patients unable to swallow tablet whole

Also known as: Dexamethasone oral tablet
Dexamethasone crushed tablets

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Allergy to dexamethasone or apple sauce and pudding
  • Unable to take medication orally

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Goettel AM, Hanson HR, Overfield J, Thornton C, Arnold DH. Tastes great, less filling! Randomized trial comparing perceived palatability of dexamethasone preparations in children. Ann Allergy Asthma Immunol. 2023 Jan;130(1):114-115. doi: 10.1016/j.anai.2022.09.016. No abstract available.

    PMID: 36596609DERIVED

MeSH Terms

Conditions

AsthmaCroup

Interventions

Calcium DobesilateDexamethasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLaryngitisLaryngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Donald H. Arnold, MD, MPH
Organization
Vanderbilt University School of Medicine
don.arnold@vumc.org
16155790516

Study Officials

  • Donald Arnold, MD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 15, 2018

Study Start

October 23, 2018

Primary Completion

October 2, 2020

Study Completion

October 2, 2020

Last Updated

November 8, 2021

Results First Posted

November 8, 2021

Record last verified: 2021-10

Locations

US(1)