Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

Adenotonsillectomy (T&A) is the one of the most common pediatric procedures performed in the
United States, with over 530,000 procedures performed annually1. Pain control after T&A is
essential for improving recovery and enhancing quality of life. At CCHMC, our current
protocol in patients over the age of three is to treat pain with scheduled Tylenol, ibuprofen
and steroids, as well as opioids (oxycodone) as a "rescue" medication for uncontrolled pain.
Despite this regimented approach, pain control is often suboptimal, and numerous doses of
opioids are often required. Montelukast is a cysteinyl leukotriene receptor antagonist that
may have a role in decreasing post T&A pain2. The primary objective of the present study is
to evaluate the effect of montelukast on post-T&A pain by measuring the amount of opioid pain
medication required postoperatively in patients receiving montelukast preoperatively compared
to those receiving placebo. The secondary objective will evaluate post-surgical outcomes and
include group comparisons of post T&A pain scores and number of Emergency department visits
and/or phone calls for perioperative pain related complaints.

Hypothesis #1 Preoperative montelukast will decrease the amount of opioid pain mediation
required in the first 24 hours postoperatively compared to those in the control group.

Hypothesis #2 Preoperative montelukast will decrease pain scores in the first 24 hours after
surgery in patients undergoing T&A compared to those in the control group.

Hypothesis#3 Preoperative montelukast will decrease the number of postoperative contacts
(Emergency department visits and phone calls) by parents for pain related concerns in the
first 3-4 weeks after surgery.

Inclusion Criteria: All patients between the ages of 3-8 undergoing adenotonsillectomy for
an indication of adenotonsillar hypertrophy who are scheduled for overnight 23 hour
observation at CCHMC main campus.

Exclusion Criteria: Patients with moderate to severe developmental delay will be excluded
due to difficulties in scoring postoperative pain. In addition, those with allergies to
Montelukast and those currently using Montelukast will be excluded. Those with moderate to
severe cardiac, hepatic, pulmonary or renal disease will be excluded. All patients with a
primary indication of chronic tonsillitis will be excluded. Those with active respiratory
infections requiring cancellation of surgery will be excluded based on the Anesthesia
services recommendations.