Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures

Completed · Phase 4 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01708122

Run by

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

People needed

71

Starts

2009-05-01

Expected to finish

2014-02-01

Last updated by the study team

2015-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Urological indications for cystoscopic procedure.

You may not qualify if…

• History of analgesia abuse or former opioid addiction.
• Allergy to fentanyl.
• Acute/chronic nasal problems such as rhinitis or sinusitis.
• Positive urine pregnancy test / lactation.
• Acute bronchial asthma / upper airway obstruction.
• Presence of bradycardia or a history of seizures.
• Concomitant use of drugs that inhibit CYP3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, MAO inhibitors and verapamil)
• 0-10 NRS pain score more than 3 on baseline.
• Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.

Where it is running

• Harbor UCLA Medical Center Urology Clinic — Torrance, California, United States

Full record on ClinicalTrials.gov

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