Clinical trial NCT01756651: Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures
Official title: A Prospective Study Comparing the Efficacy and Safety of 100 mcg and 200 mcg of Intranasal Fentanyl Pectin Spray as an Analgesic in Adult Males Undergoing Outpatient Cystoscopic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Other Acute Pain
Pain Experienced During Cystoscopy
Keywords: Intranasal fentanyl
Cystoscopy
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
Collaborators: name: Depomed
First posted: 2012-12-27
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Change from baseline in pain numeric rating scale
timeFrame: within 3 hours post administration of the drug
Secondary outcomes:
measure: Oxyhemoglobin saturation
timeFrame: Every 5 minutes post administration of the drug until 3 hours
Other outcomes:
measure: Mean arterial blood pressure
timeFrame: every 15 minutes until 3 hours post drug-administration
Locations:
city: Torrance
country: United States
facility: Urology Clinic, Harbor-UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Richard Reznichek, MD
role: PRINCIPAL_INVESTIGATOR
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