drugset / Trial / NCT02899182

Mixture Nitrous Oxide - Oxygen 50-50% in Transrectal Prostate Biopsy Guided by Ultrasound

NCT02899182

Phase 1/2 Completed 84 enrolled Fluminense Federal University
RandomizedParallel-groupDouble-blindHealth-services research

Summary

Introduction: Transrectal ultrasound-guided prostate biopsy (TUPB) is the gold standard diagnostic tool for prostate cancer and, though may be well tolerated for some patients, about 65 to 90% of then still complain of discomfort, weather associated or not to pain. Therefore, as a manner of improvement in visual analogic pain score (VAS) and satisfaction between those patients, the aim of this study is to propose the gas mixture N2O-O2 50-50%, as a non-invasive, safe and cost-effective method to deliver analgesia and/or sedation, without the need for an anesthesiologist. Materials and methods: A randomized clinical trial, simple blind, which took place in Hospital Universitário Antônio Pedro, Niteroi, RJ, within two groups containing 42 patients each, divided in conventional (C), which received 100% oxygen and nitrous oxide (NO), which received inhalation of the mixture N2O-O2 50-50% from a self-demand valve during exam. They were accessed for pain with VAS, answered a satisfaction task and were recorded about collateral side effects.

Timeline

Start
2016-04
Primary completion
2017-03
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitrous Oxide Other / unclassified 50 % Inhaled

Indications

No indication recorded.