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NCT02793375 · ClinicalTrials.gov registry record · Phase 3
Does Montelukast Decrease Post Adenotonsillectomy Pain in Children
A Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 116
- Enrollment target
NCT02793375: Completed Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02793375 is a Phase 3 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 116 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02793375, a Phase 3 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 116 participants
- Enrollment target
Study 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).
Primary Outcome
The number of patients that made a physician phone call and/or trip to the emergency room for pain related concerns in the first month after tonsillectomy.
Interventions
- DRUG Placebo
- DRUG Montelukast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2018-08-02 |
| Est. Completion | 2024-11-19 |
| Phase | Phase 3 |
What the finished NCT02793375 record still lists
NCT02793375 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02793375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02793375 about?
NCT02793375 is a clinical study titled "Does Montelukast Decrease Post Adenotonsillectomy Pain in Children". 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 O...
What is the current status of trial NCT02793375?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 116 participants. The study started on 2018-08-02. Estimated completion is 2024-11-19.
What interventions are being tested in trial NCT02793375?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG).
Who is sponsoring clinical trial NCT02793375?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02793375's enrollment target sits among peer trials
116 1643rd of 2000 higher than 357 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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