Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

Launched by RICHARD C REZNICHEK, MD · Dec 20, 2012

Keywords

ClinConnect Summary

In this prospective study, twenty subjects will be enrolled. The first ten will receive a dose of 100mcg pectin fentanyl nasal spray (Lazanda®). The second ten will receive a dose of 200mcg pectin fentanyl nasal spray (Lazanda®) if the 100mcg was well tolerated in the first ten. In all cases, Lidocaine jelly is used as an local anesthetic in the urethra.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male adult patients scheduled for cystoscopy; additional procedures (e.g. ureteral stent placement, stent exchange, bladder biopsy, retrograde pyelogram) may be included.
• Exclusion Criteria:
• • 1. History of analgesic abuse or opioid tolerance
• • 2. Allergy to fentanyl or to any of the components of Lazanda®
• • 3. Acute/chronic nasal problems such as rhinitis or sinusitis
• • 4. Acute bronchial asthma / upper airway obstruction
• • 5. Presence of bradycardia or history of seizures
• • 6. 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.
• • 7. Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline)
• • 8. Numeric Rating Scale (NRS) pain score more than 0 at baseline
• • 9. Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.