Topical nasal xylometazoline for flexible bronchoscopy (VAIN): A randomized, double-blind, placebo-controlled trial

Abstract

Background: The role of topical nasal vasoconstrictor administration during flexible bronchoscopy is unclear.

Methods: Consecutive subjects undergoing flexible bronchoscopy were randomized to receive either topical xylometazoline (0.1%) or placebo (saline nasal spray, 0.74% w/v isotonic solution) before bronchoscopy. Background topical anesthesia included 2% nasal lignocaine gel, pharyngeal spray of 10% lignocaine, and 1% lignocaine solution for spray-as-you-go administration. The primary outcome was the operator rated ease of nasal negotiation of the bronchoscope on the visual analog scale (Negotiation VAS). Secondary objectives included assistant rated facial pain scale score, patient-rated nasal pain score (Pain VAS), time to reach the vocal cords after bronchoscope insertion, operator rated nasal mucosal trauma score (Trauma VAS), hemodynamic changes, and complications between the groups.

Results: In all, 148 subjects were recruited and randomized to the placebo (73) and xylometazoline groups (75). Operator rated ease of nasal bronchoscope negotiation (Negotiation VAS) was similar in both the groups [Median (IQR), 1 (1-2) in both groups, p = 0.79]. There were no differences in the other outcomes including assistant rated score of facial pain [(Median (IQR), 2 (2-4) placebo and 2 (2-4) xylometazoline, p = 0.36], Pain VAS [Median (IQR), placebo 2 (1-2) and xylometazoline 2 (1-3), p = 0.28], Trauma VAS, [Median (IQR), placebo 1 (0-2) and xylometazoline 1 (0-1), p = 0.28], hemodynamic changes, or complications between the two groups.

Conclusion: The findings of this study do not support the administration of topical nasal xylometazoline in flexible bronchoscopy.

Trial registry: Trial registered on Clinicaltrials.gov, www.clinicaltrials.govNCT03424889, on January 02, 2018.

Keywords: Bronchoscopy; Randomized controlled trial; Xylometazoline.