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NCT01415583 · ClinicalTrials.gov registry record · NA
Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy
A NA study, sponsored by Massachusetts Eye and Ear Infirmary.
- Completed
- Registry status
- NA
- Development phase
- 314
- Enrollment target
NCT01415583 is a NA study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 314 participants.
The verdict
NCT01415583, a NA study, has completed, sponsored by Massachusetts Eye and Ear Infirmary.
- COMPLETED
- Registry status
- NA
- Development phase
- 314 participants
- Enrollment target
Study Summary
Tonsillectomy (removal of the tonsils) is a very common surgery in children. Bleeding after tonsillectomy is one of the risks of this surgery and can be more dangerous in children since they have less blood volume than adults. In order to improve recovery after tonsillectomy, steroids (medication that is a strong anti-inflammatory) are often given during the surgery. Recently, a study showed steroids given at the time of tonsillectomy increase the risk of bleeding significantly over children who did not receive steroids. This finding has raised concerns in the Ear, Nose, and Throat (ENT) community since most ENT's use steroids during tonsillectomy in children. The investigators look to explore this question further. To answer the question of whether perioperative steroid administration significantly affects the rate of post-tonsillectomy bleeding, the investigators propose to test the following hypotheses in a prospective, randomized, blinded placebo-controlled trial: dexamethasone does not cause an increase in post-operative bleeding rate in tonsillectomy.
Interventions
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01415583
The ClinicalTrials.gov registry entry for NCT01415583 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts Eye and Ear Infirmary, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dexamethasone is the first listed.
NCT01415583 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01415583 about?
NCT01415583 is a clinical study titled "Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy". Tonsillectomy (removal of the tonsils) is a very common surgery in children. Bleeding after tonsillectomy is one of the risks of this surgery and can be more dangerous in children since they have less blood volume than adults. In order to improve recovery after tonsillectomy, steroids (medication th...
What is the current status of trial NCT01415583?
This trial is currently completed. It is a NA study. The enrollment target is 314 participants. The study started on 2010-07. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01415583?
The interventions under investigation include: Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT01415583?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
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