Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Other Acute Pain Pain Experienced During Cystoscopy |
Drug: Fentanyl pectin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| 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 |
- Change from baseline in pain numeric rating scale [ Time Frame: within 3 hours post administration of the drug ] [ Designated as safety issue: No ]
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).
- Oxyhemoglobin saturation [ Time Frame: Every 5 minutes post administration of the drug until 3 hours ] [ Designated as safety issue: Yes ]Pulse oximetry will be recorded at baseline and every 5 minutes for 3 hours post drug-administration.
- Mean arterial blood pressure [ Time Frame: every 15 minutes until 3 hours post drug-administration ] [ Designated as safety issue: Yes ]Will be recorded at baseline and every 15 minutes for 3 hours post drug-administration.
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intranasal Fentanyl 100mcg
fentanyl pectin nasal spray 100mcg
|
Drug: Fentanyl pectin
comparison of Intranasal fentanyl 100mcg vs 200 mcg.
Other Names:
|
|
Experimental: Intranasal Fentanyl 200mcg
fentanyl pectin nasal spray 200mcg
|
Drug: Fentanyl pectin
comparison of Intranasal fentanyl 100mcg vs 200 mcg.
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Male adult patients scheduled for rigid 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.
Contacts and Locations| Contact: Richard Reznichek, MD | 3102222724 | rreznichek@dhs.lacounty.gov |
| United States, California | |
| Urology Clinic, Harbor-UCLA Medical Center | Not yet recruiting |
| Torrance, California, United States, 90502 | |
| Principal Investigator: | Richard Reznichek, MD | University of California, Los Angeles |
More Information
Publications:
| Responsible Party: | Richard C Reznichek, MD, Medical Doctor, Los Angeles Biomedical Research Institute |
| ClinicalTrials.gov Identifier: | NCT01756651 History of Changes |
| Other Study ID Numbers: | 20812-01 |
| Study First Received: | December 20, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Los Angeles Biomedical Research Institute:
|
Intranasal fentanyl Cystoscopy |
Additional relevant MeSH terms:
|
Fentanyl Pectin Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Antidiarrheals Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013