Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

Richard C Reznichek, MD

Status and phase: Completed; Phase 1

Conditions: Pain Experienced During Cystoscopy; Other Acute Pain

Treatments: Drug: Fentanyl pectin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01756651

20812-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Intranasal Fentanyl 100mcg

Experimental group

Description:

fentanyl pectin nasal spray 100mcg

Treatment:

Drug: Fentanyl pectin

Intranasal Fentanyl 200mcg

Experimental group

Description:

fentanyl pectin nasal spray 200mcg

Treatment:

Drug: Fentanyl pectin