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Does Montelukast Decrease Post Adenotonsillectomy Pain in Children
Sponsor: Children's Hospital Medical Center, Cincinnati
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).
Official title: Does Montelukast Decrease Post Adenotonsillectomy Pain in Children? A Randomized Controlled Trial
Key Details
Gender
All
Age Range
3 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2018-08-02
Completion Date
2024-11-19
Last Updated
2026-04-21
Healthy Volunteers
Yes
Conditions
Interventions
Montelukast
Age appropriate dose of Montelukast given to patients prior to undergoing adenotonsillectomy, and the day after surgery, with pain scores and amount of opioid pain medication required measured postoperatively.
Placebo
Age appropriate dose of placebo given to patients prior to undergoing adenotonsillectomy, and the day after surgery, with pain scores and amount of opioid pain medication required measured postoperatively.
Locations (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States