Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Montelukast

Criteria

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.