drugset / Trial / NCT02793375

Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

NCT02793375

Phase 3 Completed 116 enrolled Children's Hospital Medical Center, Cincinnati
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2018-08-02
Primary completion
2024-11-19
Completion
2024-11-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Montelukast Other / unclassified

Indications

No indication recorded.