Does Montelukast Decrease Post Adenotonsillectomy Pain in Children
Status:
Recruiting
Trial end date:
2022-08-31
Target enrollment:
Participant gender:
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).