Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain

In brief

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).

Key facts

Study ID
NCT02793375
Run by
Children's Hospital Medical Center, Cincinnati
People needed
116
Starts
2018-08-02
Expected to finish
2024-11-19
Last updated by the study team
2026-04-21

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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