NCT01415583

Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Detailed description is entered above

Conditions

• Post-operative Hemorrhage

Interventions

Type	Name	Description
DRUG	Dexamethasone	0.5mg/kg (max dose 20mg)

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-08-12
• Last updated: 2017-07-12
• Results posted: 2017-07-12

Locations

1 site across 1 country: United States