Phase 3
N=100
Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement
Chronic Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT01188551 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: FLACC Behavioral Pain Assessment Scale Scores — 5; 3; 1; 2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexmedetomidine (Drug); Fentanyl (Drug); Midazolam (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Nationwide Children's Hospital
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FLACC Behavioral Pain Assessment Scale Scores |
5; 3; 1; 2 | — |
| SECONDARY Recovery From General Anesthesia |
8.67; 9; 9.25; 9.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease)
- patients scheduled for placement of bilateral myringotomy tubes
Exclusion Criteria
- history of allergy to either dexmedetomidine or fentanyl
- concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.
Data sourced from ClinicalTrials.gov (NCT01188551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.