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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: Completed NA study, sponsored by Massachusetts Eye and Ear Infirmary.
NCT01415583 is a NA study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 314 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01415583 record still lists
NCT01415583 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Dexamethasone is the first listed.
NCT01415583 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01415583's enrollment target sits among peer trials
314 323rd of 2000 higher than 1,678 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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