Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

Phase 1

Completed

• Conditions: Other Acute Pain; Pain Experienced During Cystoscopy
• Interventions: Drug: Fentanyl pectin

• Registration Number: NCT01756651
• Lead Sponsor: Richard C Reznichek, MD

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.

Study Timeline

• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-27
• Study Start: 2013-02
• Primary Completion: 2016-05-10
• Study Completion: 2016-05-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Fentanyl 100mcg	Fentanyl pectin	fentanyl pectin nasal spray 100mcg
Intranasal Fentanyl 200mcg	Fentanyl pectin	fentanyl pectin nasal spray 200mcg

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain numeric rating scale	within 3 hours post administration of the drug	The primary endpoint is the worst pain experienced at any time during the procedure.; Pain will be assessed using the Numeric Rating Scale (NRS score 0 = no pain to 10 = worst possible pain).

Secondary Outcome Measures

Name	Time	Method
Oxyhemoglobin saturation	Every 5 minutes post administration of the drug until 3 hours	Pulse oximetry will be recorded at baseline and every 5 minutes for 3 hours post drug-administration.

Trial Locations

Locations (1)

Urology Clinic, Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States