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| Name | Class |
|---|---|
| Depomed | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Fentanyl 100mcg | Experimental | fentanyl pectin nasal spray 100mcg |
|
| Intranasal Fentanyl 200mcg | Experimental | fentanyl pectin nasal spray 200mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl pectin | Drug | comparison of Intranasal fentanyl 100mcg vs 200 mcg. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Reznichek, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Clinic, Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18206920 | Background | Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18. | |
| 16679829 | Background | Taghizadeh AK, El Madani A, Gard PR, Li CY, Thomas PJ, Denyer SP. When does it hurt? Pain during flexible cystoscopy in men. Urol Int. 2006;76(4):301-3. doi: 10.1159/000092051. |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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