Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain Experienced During Cystoscopy, Other Acute Pain

Intervention / Treatment
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* Drug: Fentanyl pectin


Participation Criteria
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Eligibility Criteria
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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: History of analgesic abuse or opioid tolerance Allergy to fentanyl or to any of the components of Lazanda® Acute/chronic nasal problems such as rhinitis or sinusitis Acute bronchial asthma / upper airway obstruction Presence of bradycardia or history of seizures 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. Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline) Numeric Rating Scale (NRS) pain score more than 0 at baseline Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Fentanyl 100mcg<br>fentanyl pectin nasal spray 100mcg | Drug: Fentanyl pectin<br>* comparison of Intranasal fentanyl 100mcg vs 200 mcg.<br>* Other names: Fentanyl;|
| Experimental: Intranasal Fentanyl 200mcg<br>fentanyl pectin nasal spray 200mcg | Drug: Fentanyl pectin<br>* comparison of Intranasal fentanyl 100mcg vs 200 mcg.<br>* Other names: Fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intranasal fentanyl, Cystoscopy