Post-operative Hemorrhage
Conditions
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 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
Interventions
DRUGDexamethasone
0.5mg/kg (max dose 20mg)
Sponsors
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Post-tonsillectomy Bleeding | 2 weeks after surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saline Dexamethasone: 0.5mg/kg (max dose 20mg) | 157 |
| Dexamethasone Dexamethasone: 0.5mg/kg (max dose 20mg) | 157 |
| Total | 314 |
Baseline characteristics
| Characteristic | Saline | Dexamethasone | Total |
|---|---|---|---|
| Age, Continuous | 6 years | 6 years | 6 years |
| Sex: Female, Male Female | 69 Participants | 75 Participants | 144 Participants |
| Sex: Female, Male Male | 88 Participants | 82 Participants | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 157 | 0 / 157 |
| other Total, other adverse events | 0 / 157 | 0 / 157 |
| serious Total, serious adverse events | 0 / 157 | 0 / 157 |
Outcome results
Primary
Number of Participants With Post-tonsillectomy Bleeding
Time frame: 2 weeks after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saline | Number of Participants With Post-tonsillectomy Bleeding | 13 participants |
| Dexamethasone | Number of Participants With Post-tonsillectomy Bleeding | 17 participants |
p-value: 0.05t-test, 1 sided
p-value: 0.05t-test, 1 sided