NCT04563494

Brief Summary

The hypothesis being tested in this study is that perioperative oral administration of dexamethasone, when compared to intravenous (IV) administration, offers a similar reduction in postoperative nausea and vomiting (PONV), and reduction in postoperative pain in pediatric patients undergoing tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement. The specific aim of this study is to demonstrate non-inferiority of oral dexamethasone when compared to IV dexamethasone, given that there is currently a severe, sudden, and world-wide shortage of IV dexamethasone given its recent use in treating patients with covid19 disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

October 23, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

2.6 years

First QC Date

September 18, 2020

Last Update Submit

July 18, 2024

Conditions

Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Incidence of post op nausea and vomiting

    post-op nausea and vomiting as evidenced by vomiting and/or retching without expulsion of gastric content

    4 hours

Secondary Outcomes (1)

  • pain scores and surgical re-exploration for bleeding

    4 hours

Study Arms (2)

IV Dexmethsone and oral placebo

ACTIVE COMPARATOR
Drug: dexamethasone

Oral dexamethasone and IV placebo

ACTIVE COMPARATOR
Drug: dexamethasone

Interventions

dexamethasoneDRUG

Prevention of post op nausea and vomiting

IV Dexmethsone and oral placeboOral dexamethasone and IV placebo

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • tonsillectomy with or without adenoidectomy and tympanostomy tube placement

You may not qualify if:

  • Subjects receiving one week before surgery:
  • -antiemetics
  • steroids
  • anti-histaminic
  • psychoactive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Melissa Brooks Peterson, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 24, 2020

Study Start

October 23, 2020

Primary Completion

May 24, 2023

Study Completion

May 24, 2023

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)