Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery

Phase 4 Completed 45 enrolled Marc Tewfik

RandomizedParallel-groupSingle-blindOther

Summary

The purpose of our study is to assess the effect of topical vasoconstriction (cocaine 4% versus adrenaline 1/1000) on the surgical field during endoscopic sinus surgery.

Timeline

Start: 2012-12
Primary completion: 2013-12
Completion: 2013-12

Outcome

Missed primary endpoint

registry MEAN Cocaine SIDE: 2.17 (Standard Deviation 0.70) units on a scale MEAN Adrenaline SIDE: 2.04 (Standard Deviation 0.75) units on a scale analysis (superiority or other test); Cocaine SIDE vs Adrenaline SIDE; p = 0.05; t-test, 2 sided NCT01706952 ↗

paper There was no difference in the mean surgical field scores between the adrenaline and cocaine sides (2.04 ± 0.75 vs 2.17 ± 0.7, p = 0.24), nor the PMID 24678064 ↗

Publications

Results Valdes CJ, Bogado M, Rammal A, Samaha M, Tewfik MA. Topical cocaine vs adrenaline in endoscopic sinus surgery: a blinded randomized controlled study. Int Forum Allergy Rhinol. 2014 Aug;4(8):646-50. doi: 10.1002/alr.21325. Epub 2014 Mar 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cocaine	Small molecule	4 %	Intranasal
Subject	Epinephrine	Other / unclassified	0.1 %	Intranasal