At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
Dexmedetomidine +2 moredrug
Likely dose
Dexmedetomidine 1 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl
In Brief
A Phase 3 clinical trial evaluating Dexmedetomidine, Fentanyl, and 1 other intervention for Chronic Otitis Media. Completed, enrolled 100 participants across 1 site.
Detailed Summary
This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Otitis Media
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartJan 2011
Primary CompletionApr 2012
TodayJul 2026
First PostedAug 25, 2010
Enrollment StartJan 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.9 years ago
Interventions
Dexmedetomidinedrug
dexmedetomidine (1 µg/kg) will be administered intranasally
Fentanyldrug
fentanyl (2 µg/kg) will be administered intranasally
Midazolamdrug
Sedative given pre-op.