Does Montelukast Decrease Post Adenotonsillectomy Pain in Children
Does Montelukast Decrease Post Adenotonsillectomy Pain in Children
Objective: The purpose of the present study is to evaluate the effectiveness of preoperative
 Montelukast as an analgesic for adenotonsillectomy

 Study Design: Randomized controlled double blinded clinical trial.

 Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric
 Otolaryngology, Head and Neck Surgery

 Methods: Children between the age of 3-8 undergoing adenotonsillectomy with planned 23 hour
 observation for adenotonsillar hypertrophy and sleep disordered breathing will be randomized
 to receive either montelukast or placebo in Same Day surgery.

 Analysis: Differences in demographics (age, gender, race, weight) between the intervention
 and control groups will be assessed using chi-square (for categorical measures) and t tests
 (for continuous measures). Differences in postoperative opioid usage, postoperative pain
 scores using the FLACC scale, and the number of postoperative contacts (Emergency department
 visits or phone calls) with patients or their family regarding pain or tonsillar hemorrhage
 will be evaluated using chi-square (categorical measures) and t tests (continuous measures).
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.