Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children

Indications for surgery for pediatric chronic rhinosinusitis currently lacks scientific
consensus. In general, children who fail medical management are candidates for surgery.
Currently, pre-operative evaluation with a CT scan of the sinuses is the gold standard prior
to sinus surgery. However, the role of the adenoids and adenoiditis in pediatric chronic
sinusitis is incompletely understood. Adenoids may contribute to sinusitis both as a
bacterial reservoir and obstruct nasal secretion drainage, owing to their larger relative
size in children. Adenoidectomy alone has been found to improve symptoms in 75% of children.

It has been found that 50% of children continued to be symptomatic after adenoidectomy, and
went on to require endoscopic sinus surgery (ESS). In addition, of the group that failed, 58%
had asthma. Overall, asthma and age have been the only known risk factors for failure of
adenoidectomy.

Specific Objectives The objectives of this study would be to determine the most effective
management for pediatric patients with chronic rhinosinusitis and asthma who fail medical
management. Outcomes will be evaluated using the SN-5, a validated tool used to track
symptoms of pediatric chronic rhinosinusitis. A decrease in at least 0.5 is felt to represent
an improvement in symptom control. In this study, the SN-5 at one year post intervention will
be the primary endpoint. Secondary endpoints include complications, revision surgery, and
post operative endoscopy scores.

Study Design

The primary outcome is the SN-5 score one year post surgery. A change of 0.5-1.0 is
considered a mild improvement, while a change of at least 1.0 is considered a moderate
improvement.

Sixty patients are required to have an 80% chance of detecting, as significant at the 5%
level, an increase in the primary outcome measure from 47% in the control group to 80% in the
experimental group.

Statistical Methods:

Univariate statistical analysis using chi-square in analysis of binary outcomes. In addition
paired t test of preoperative and postoperative SN-5 scores will be performed.

Data Analysis and Interpretation:

Analysis of SN-5, and comparison of Lund-McKay(CT) scores along with post operative endoscopy
Kennedy scores.

Study Procedures:

The patient's will initially be seen as a referral to the otolaryngology clinic for symptoms
including chronic rhinosinusitis. If they meet inclusion criteria, they will be offered
enrollment into the study and consent will be obtained. Their symptoms will be followed at
each visit with the SN-5, a validated symptom-scoring tool to evaluate pediatric chronic
rhinosinusitis.

If the patient does not improve with medical therapy alone after review of the SN-5 and in
discussion with caregivers, he or she will be offered entry into the study, with consent, CT
scan of the sinuses, and will be randomized to two different treatment arms. The first is
adenoidectomy. The patient will then be followed at defined intervals with evaluation of
symptoms by SN-5. Should symptoms worsen or not improve, they will then be offered endoscopic
sinus surgery, with findings from the CT scan of the sinuses to guide operative intervention.
Adenoidectomy followed by endoscopic sinus surgery is the current standard of care and serves
as the control arm. In the other experimental or study arm, the patient will undergo
adenoidectomy with endoscopic sinus surgery at the same time. Radioallergosorbent test blood
testing for allergies would be performed at the time of surgery in both groups.

For patients who initially improve with medical therapy, but relapse at a later time, they
may either undergo consent and randomization if they relapse within a year or a repeat course
of medical therapy if it has been one year since previous medical therapy.

Endoscopic sinus surgery, in both arms would be tailored to abnormal findings in the CT scan,
as is the standard of care. Radiologists typically examine sinonasal disease of the sinuses,
and they would also be requested to comment on the patency of the osteo-meatal unit, as this
is a component of the Lund-McKay score. The Lund-McKay score is an objective radiologic grade
of the severity of sinusitis. If there is sinus thickening, or narrowing of the osteomeatal
unit, endoscopic sinus surgery would be tailored to this using either balloon sinuplasty or
traditional antrostomy. Patient undergoing endoscopic sinus surgery will likely have at least
a maxillary antrostomy and anterior ethmoidectomy performed, with frontal sinusotomy,
posterior ethmoidectomy, and sphenoidotomy performed depending on CT or endoscopy findings.

Inclusion Criteria:

1. Age 6-12 at time of study enrollment.

2. Presence of chronic sinusitis: >90 days 2 or more symptoms of purulent rhinorrhea,
nasal obstruction, facial pressure/pain, or cough

3. Presence of asthma, as documented in the medical record by the patient's pediatrician
and/or pulmonologist

4. Failure of medical management of pediatric chronic rhinosinusitis, which current
guidelines recommend extended empiric antibiotics for 21 days, which will be either
Augmentin or clindamycin in penicillin allergic patients, at standard pediatric weight
based dosing. In addition, Flonase nasal spray and nasal saline treatment for three
weeks. Failure is considered persistent symptoms despite treatment with the above
within the past year.

Exclusion Criteria:

1. Previous sinus surgery,

2. Previous adenoidectomy, or

3. Presence of cystic fibrosis,

4. Presence of antrochoanal polyp,

5. Immunodeficiency

6. Fungal infection.