Post-operative Hemorrhage Clinical Trial
Official title:
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 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.
| Status | Completed |
| Enrollment | 314 |
| Est. completion date | November 2011 |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts Eye and Ear Infirmary |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with post-tonsillectomy bleeding | The primary objective of this study is to determine if dexamethasone at 0.5mg/kg (max dose 20mg) is associated with an increased rate of post-tonsillectomy hemorrhage in children when compared to placebo. | 2 weeks after surgery | Yes |
| Secondary | To compare rate of post-tonsillectomy hemorrhage when studying different groups of patients based on age, indication for surgery, or operating surgeon. | The second objective of this study is to use a multivariate logistic regression model to determine if bleeding rates differed according to surgical indication, age, or operating surgeon. This is important since indication for tonsillectomy varies in children. Younger children tend to undergo tonsillectomy for obstructive sleep symptoms whereas older children tend to have the indication for tonsillectomy based on infectious tonsillitis. | 2 weeks after surgery | Yes |