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Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

NCT01756651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-05-11

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of intranasally-administrated fentanyl pectin spray (Lazanda®)given 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 local pain. In this study, an additional medicine (Lazanda®) is used to reduce pain that occurs during and after the above procedure.

Conditions

  • Other Acute Pain
  • Pain Experienced During Cystoscopy

Interventions

DRUG

Fentanyl pectin

comparison of Intranasal fentanyl 100mcg vs 200 mcg.

Sponsors & Collaborators

  • Depomed

    collaborator INDUSTRY

  • Richard C Reznichek, MD

    lead OTHER

Principal Investigators

  • Richard Reznichek, MD · University of California, Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-05-10
Completion
2016-05-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01756651 on ClinicalTrials.gov