CompletedPhase 1

Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

United States20 participantsStarted 2013-02

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Exclusion criteria

✕. 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

What they're measuring

Change from baseline in pain numeric rating scale

Timeframe: within 3 hours post administration of the drug

Trial details

NCT IDNCT01756651

SponsorRichard C Reznichek, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05-10

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