CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 71 enrolled
Drug / intervention
Fentanyl +1 moredrug
Likely dose
Fentanyl 100 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01708122
NCT01708122Phase 4Completed

A Prospective, Randomized, Double Blind Study Comparing the Efficacy and Safety of Fentanyl Nasal Spray to Placebo as an Analgesic, in Patients Undergoing Outpatient Cystoscopic Procedures

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·interventional·Posted Oct 16, 2012·Updated Aug 20, 2015

In Brief

A Phase 4 clinical trial evaluating Fentanyl and saline for Pain. Completed, enrolled 71 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the efficacy of intranasally-administrated fentanyl spray to decrease the pain during cystoscopy (the passage of a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any other problems with the urinary bladder). The current standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to lubricate and decrease pain. In this study, an additional medicine (fentanyl) is used to reduce pain that occurs during and after the above procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2012
Enrollment StartMay 1, 2009
Primary CompletionMar 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.7 years ago

Interventions

Fentanyldrug

100 mcg in 1 mL intranasal spray

salinedrug

Sodium Chloride 0.9% intranasal spray