Topical Microporous Polysaccharide Hemospheres Versus Electrocautery for Control of Pediatric Post-Tonsillectomy Bleeding

Inclusion Criteria:

Eligibility is contingent on the presence of following characteristics:

1. Children and adolescents age 5-18 years old. The lower age range is chosen in order
to spare younger, smaller children who have less circulating volume to decrease any
potential unwarranted risks of increased bleeding. The upper age range is chosen
because our ultimate focus is to determine whether this therapy can help the
pediatric population prevent the need for electrocautery under anesthesia for
tonsil-related bleeding.

2. Obstructive sleep disorder symptomatology requiring surgical intervention. The
presence of obstructive sleep disorder is determined according to the practice of the
otolaryngologist investigator, and includes at least two of the following: medical
history, physical exam findings, nasopharyngoscopy, lateral x-ray, sleep videotape,
or polysomnography. In addition, the mean survey score on the OSD-6 (which is an
instrument validated in children with obstructive sleep disorder (See Figure 2)) is
at least 3, which corresponds to a moderate degree of symptoms (0 no symptoms, 6
symptoms could not be worse).

3. Tonsillar or adenotonsillar hypertrophy. Tonsillar hypertrophy is defined as at least
3+ tonsillar hypertrophy on a scale of 1+ to 4+, with the following definition of
grades of obstruction determined by visual inspection: 1+ 0-25%, 2+ 26-50%, 3+
51-75%, 4+ 76-100%.

4. Bilateral microdebrider tonsillotomy. This method of surgery is chosen because it (1)
is a standard technique utilized by the surgeons involved in this study as treatment
of obstructive tonsillar hypertrophy and (2) results in a relatively uniform,
reproducible bleeding surface that requires hemostasis following tonsil removal.

Exclusion Criteria:

Eligibility is contingent on the absence of following characteristics:

1. Personal or family history of bleeding diathesis or easy bruising. The introduction
of this confounder should be avoided, given that the primary outcome is adequacy of
hemostasis. Given that preoperative laboratory evaluation in the setting of no
suggestive history has been shown to have low predictive values for successful
perioperative hemostasis, enrolled subjects receive no preoperative laboratory
screening.

2. Intake of non-steroidal anti-inflammatory drugs within 14 days prior to surgery.
Although there are several trials that suggest that postoperative administration of
these drugs may have no impact on hemorrhage, the topic remains controversial due to
the large numbers of subjects required to achieve adequate power in such studies.
Thus, the introduction of this potential confounder is avoided, given that the
primary outcome is adequacy of hemostasis.

3. Liver dysfunction. This disease state may also confound evaluation of hemostasis.

4. Cardiac, renal, or blood pressure disorder. These states may make children less
tolerant of hemorrhage, and so they are excluded in order to minimize risk.

5. Chronic inflammation states, such as recurrent pharyngitis, may result in an
increased propensity toward bleeding, and thus subjects with this potential
confounder are excluded. Children with 3 or more acute pharyngitis episodes within
the past year are excluded. A pharyngitis episode is defined as documentation by
physician of the episode and >1 of the following: oral >38.3 degrees C,
lymphadenopathy >2cm or tender lymphadenopathy, tonsil/pharyngeal exudates, group A
beta hemolytic streptococcus positive, or antibiotic administration for
proved/suspected streptococcal infection.

6. Implant contraindications to the use of monopolar electrocautery. Metal implants
would preclude safe randomization to the electrocautery treatment arm. There are no
suspected or known contraindications to application of MPH at the tonsillar fossae.

7. Allergic or adverse reactions to requisite perioperative medications. The current
protocol calls for the use of an antibiotic and narcotic pain medication in all
subjects, with one second-line agent as a planned alternative. Thus, inability to
tolerate both penicillin and macrolide antibiotics, or both oxycodone and codeine
narcotics, precludes entry into the trial.

8. Children whose caregivers cannot commit to the 2 week follow up schedule. This
schedule includes daily calls to evaluate bleeding and pain control.

9. Cognitive inability to report bleeding, adverse events, or pain control. Thus,
children with mental retardation, communication disorders, developmental delay, and
chronic pain states are also excluded.