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

Outcome

Outcome not reported

Stopped: “Due to staffing changes in the hospital, we will be unable to complete this study for the requested 84 subjects. As such, we have decided to close this study.”

Drugs

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