TonsillectomyNCT02228135
The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage
An observational study of Tonsillectomy and Adenotonsillectomy, run by Nicole Elsey at 1 site in United States.
Trial summary
This is a retrospective chart review looking at the effect of dexamethasone dosing on post-tonsillectomy hemorrhage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tonsillectomy, Adenotonsillectomy
- What is being tested?
- Dexamethasone
- How many people
- 9,843 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children who have had tonsillectomy or adenotonsillectomy
Who may be able to join
- Patients undergoing a tonsillectomy
- Patients undergoing an adenotonsillectomy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is a retrospective chart review looking at the effect of dexamethasone dosing on post-tonsillectomy hemorrhage.
- Conditions
- Tonsillectomy, Adenotonsillectomy
- Being tested
- Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Non post-tonsillectomy hemorrhage | Children who do not have post-tonsillectomy hemorrhage. Receives: Drug: Dexamethasone | |
| Post-tonsillectomy hemorrhage | Children return to the hospital after surgery with post-tonsillectomy hemorrhage. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dexamethasone Dosage
Measured: once at start of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicole Elsey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicole Elsey, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228135
- Sponsor's protocol ID
- IRB14-00588
- Status last verified
- Jul 2017
- First submitted
- 27 Aug 2014
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage
- ClinicalTrials.gov ID
- NCT02228135
- Acronym / sponsor ID
- IRB14-00588
- Conditions
- Tonsillectomy, Adenotonsillectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,843 participants (actual)
- Lead sponsor
- Nicole ElseyUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective chart review looking at the effect of dexamethasone dosing on post-tonsillectomy hemorrhage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non post-tonsillectomy hemorrhage | – | Drug: DexamethasoneChildren who do not have post-tonsillectomy hemorrhage. |
| Post-tonsillectomy hemorrhage | – | Drug: DexamethasoneChildren return to the hospital after surgery with post-tonsillectomy hemorrhage. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children who have had tonsillectomy or adenotonsillectomy
Key inclusion criteria (2 listed)
- Patients undergoing a tonsillectomy
- Patients undergoing an adenotonsillectomy
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone | Drug | Non post-tonsillectomy hemorrhage, Post-tonsillectomy hemorrhage |
Primary outcome
Dexamethasone Dosage
Time frame: once at start of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillectomy and Adenotonsillectomy, run by Nicole Elsey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dexamethasone Dosage (time frame: once at start of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.