drugset / Trial / NCT03847922

Nitrous Oxide for Analgesia During Office Urethral Bulking

NCT03847922

Phase 4 Terminated 2 enrolled Baylor Research Institute
RandomizedParallel-groupSingle-blindTreatment

Summary

This study is designed to determine primarily if there is a difference in perceived pain in patients receiving urethral bulking with calcium hydroxylapatite using local lidocaine versus local lidocaine plus nitrous oxide gas. Patients will be randomized to a control group (local lidocaine plus room air) or a intervention group (local lidocaine plus 50% nitrous oxide/50% oxygen inhaled mixture). Their pain will be assessed immediately after the procedure, and their recollection of pain will also be assessed at their 2 week post-procedure visit. There are other secondary outcome measures as well; please see outcome measures section for full description.

Timeline

Start
2019-02-15
Primary completion
2020-07-23
Completion
2020-07-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitrous Oxide Other / unclassified 50 % Inhaled
Background Lidocaine Other / unclassified 6 ml Other