Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

Completed · Phase 1

Conditions studied: Other Acute Pain, Pain Experienced During Cystoscopy

In brief

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.

Key facts

Study ID

NCT01756651

Run by

Richard C Reznichek, MD

People needed

20

Starts

2013-02-01

Expected to finish

2016-05-10

Last updated by the study team

2017-05-11

Who can join

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

You may qualify if…

• Male adult patients scheduled for cystoscopy; additional procedures (e.g. ureteral stent placement, stent exchange, bladder biopsy, retrograde pyelogram) may be included.

You may not qualify if…

• History of analgesic abuse or opioid tolerance
• Allergy to fentanyl or to any of the components of Lazanda®
• Acute/chronic nasal problems such as rhinitis or sinusitis
• Acute bronchial asthma / upper airway obstruction
• Presence of bradycardia or history of seizures
• Concomitant use of drugs that inhibit cytochrome P450 isoenzyme 3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, monoamine oxidase inhibitors and verapamil) or exposure to these drugs 30 days prior to placement on the study.
• Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline)
• Numeric Rating Scale (NRS) pain score more than 0 at 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

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

Full record on ClinicalTrials.gov

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