Last reviewed · How we verify
NCT02793375: Montelukast
Does Montelukast Decrease Post Adenotonsillectomy Pain in Children
Phase 3 trial testing Montelukast in Pain in 117 participants. Completed in 19 November 2024.
19 November 2024
Quick facts
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 117 |
| Start date | 2 August 2018 |
| Primary completion | 19 November 2024 |
| Estimated completion | 19 November 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Montelukast (montelukast) — full drug profile →
- Placebo
Conditions studied
- Pain — all drugs for Pain →
Sponsor
Children's Hospital Medical Center, Cincinnati
Who can join
Adults 3 to 8, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02793375
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Children's Hospital Medical Center, Cincinnati trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02793375 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati
- Last refreshed: 22 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02793375.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing