Phase 3 Completed N=100 Randomized Quadruple-blind Treatment

Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

Chronic Otitis Media

Source: ClinicalTrials.gov NCT01188551 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcomePrimary: FLACC Behavioral Pain Assessment Scale Scores — 5; 3; 1; 2 units on a scale

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.

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	—

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.

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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. Informational only — not medical advice.