NCT02228135

Brief Summary

This is a retrospective chart review looking at the effect of dexamethasone dosing on post-tonsillectomy hemorrhage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,843

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

2.4 years

First QC Date

August 27, 2014

Last Update Submit

July 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dexamethasone Dosage

    once at start of surgery

Study Arms (2)

Non post-tonsillectomy hemorrhage

Children who do not have post-tonsillectomy hemorrhage.

Drug: Dexamethasone

Post-tonsillectomy hemorrhage

Children return to the hospital after surgery with post-tonsillectomy hemorrhage.

Drug: Dexamethasone

Interventions

Non post-tonsillectomy hemorrhagePost-tonsillectomy hemorrhage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children who have had tonsillectomy or adenotonsillectomy

You may qualify if:

  • Patients undergoing a tonsillectomy
  • Patients undergoing an adenotonsillectomy

You may not qualify if:

  • All patients with a known history of bleeding or clotting disorders, as well as those patients who had presented to Nationwide Children's Hospital main operating room for control of PTH but had their initial tonsillectomy/adenotonsillectomy at an outlying facility will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

August 27, 2014

First Posted

August 28, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations