CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 314 enrolled
Drug / intervention
Dexamethasonedrug
Likely dose
Dexamethasone 0.5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01415583
NCT01415583N/ACompleted

Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

Massachusetts Eye and Ear Infirmary·interventional·Posted Aug 12, 2011·Updated Jul 12, 2017

In Brief

A clinical study evaluating Dexamethasone for Post-operative Hemorrhage. Completed, enrolled 314 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 12, 2011
Enrollment StartJul 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.9 years ago

Interventions

Dexamethasonedrug

0.5mg/kg (max dose 20mg)