Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

Other Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756651
• Other study ID #: 20812-01
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2012
• Last updated: May 10, 2017
• Start date: February 2013
• Est. completion date: May 10, 2016

Study information

• Verified date: May 2017
• Source: Los Angeles Biomedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 10, 2016
• Est. primary completion date: May 10, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Other Acute Pain
• Pain Experienced During Cystoscopy

Intervention

Drug:
• Fentanyl pectin
comparison of Intranasal fentanyl 100mcg vs 200 mcg.

Locations

Country	Name	City	State
United States	Urology Clinic, Harbor-UCLA Medical Center	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Richard C Reznichek, MD	Depomed

Country where clinical trial is conducted

United States, 

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean arterial blood pressure	Will be recorded at baseline and every 15 minutes for 3 hours post drug-administration.	every 15 minutes until 3 hours post drug-administration
Primary	Change from baseline in pain numeric rating scale	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).	within 3 hours post administration of the drug
Secondary	Oxyhemoglobin saturation	Pulse oximetry will be recorded at baseline and every 5 minutes for 3 hours post drug-administration.	Every 5 minutes post administration of the drug until 3 hours