Status:
COMPLETED
Does Montelukast Decrease Post Adenotonsillectomy Pain in Children
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Pain
Eligibility:
All Genders
3-8 years
Phase:
PHASE3
Brief 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 clin...
Detailed Description
Adenotonsillectomy (T\&A) is the one of the most common pediatric procedures performed in the United States, with over 530,000 procedures performed annually1. Pain control after T\&A is essential for ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT02793375
Start Date
August 2 2018
End Date
November 19 2024
Last Update
November 22 2024
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229