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Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

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ClinicalTrials.gov Identifier: NCT01756651
Recruitment Status : Completed
First Posted : December 27, 2012
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Depomed
Information provided by (Responsible Party):
Richard C Reznichek, MD, Los Angeles Biomedical Research Institute

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.

Condition or disease Intervention/treatment Phase
Other Acute Pain Pain Experienced During Cystoscopy Drug: Fentanyl pectin Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Actual Study Start Date : February 2013
Actual Primary Completion Date : May 10, 2016
Actual Study Completion Date : May 10, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intranasal Fentanyl 100mcg
fentanyl pectin nasal spray 100mcg
Drug: Fentanyl pectin
comparison of Intranasal fentanyl 100mcg vs 200 mcg.
Other Names:
  • Lazanda
  • Fentanyl

Experimental: Intranasal Fentanyl 200mcg
fentanyl pectin nasal spray 200mcg
Drug: Fentanyl pectin
comparison of Intranasal fentanyl 100mcg vs 200 mcg.
Other Names:
  • Lazanda
  • Fentanyl




Primary Outcome Measures :
  1. Change from baseline in pain numeric rating scale [ Time Frame: 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 :
  1. Oxyhemoglobin saturation [ Time Frame: 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.


Other Outcome Measures:
  1. Mean arterial blood pressure [ Time Frame: every 15 minutes until 3 hours post drug-administration ]
    Will be recorded at baseline and every 15 minutes for 3 hours post drug-administration.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756651


Locations
United States, California
Urology Clinic, Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
Richard C Reznichek, MD
Depomed
Investigators
Principal Investigator: Richard Reznichek, MD University of California, Los Angeles

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
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Richard C Reznichek, MD, Los Angeles Biomedical Research Institute:
Intranasal fentanyl
Cystoscopy

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Pectin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antidiarrheals
Gastrointestinal Agents