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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 is a Phase 3 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 116 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02793375
The ClinicalTrials.gov registry entry for NCT02793375 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02793375 reports 0 study locations.
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.
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