Status:
COMPLETED
Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Post-operative Hemorrhage
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief 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...
Detailed Description
Detailed description is entered above
Eligibility Criteria
Inclusion
- Patients ages 3 to 18 undergoing tonsillectomy or adenotonsillectomy by electrocautery alone for the indication of sleep disordered breathing or infectious tonsillitis.
- Patients with complex medical conditions or craniofacial abnormalities will be included.
- Informed consent and child assent are required for enrollment.
- Eligibility will be determined by the principal investigator, associate investigator or research nurse.
Exclusion
- Subjects with a known personal or family history of any bleeding disorder will be excluded.
- Subjects currently on oral corticosteroids for other medical conditions or have recently taken any oral corticosteroid within two weeks of surgery.
- Patients with tonsillectomy performed using a cold knife technique, microdebrider, coblation or plasma knife due to surgeon or parent preference.
- Where appropriate subjects who do not have informed consent or child assent signed will be excluded
- Children less than three years old will be excluded due to the fact the majority of these children at the collaborating centers have an adenotonsillectomy using the microdebrider for pain control purposes.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT01415583
Start Date
July 1 2010
End Date
November 1 2011
Last Update
July 12 2017
Active Locations (1)
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1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114