Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Los Angeles Biomedical Research Institute
Sponsor:
Collaborator:
Depomed
Information provided by (Responsible Party):
Richard C Reznichek, MD, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT01756651
First received: December 20, 2012
Last updated: October 30, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • 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).



Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 2014
Estimated Primary Completion Date: February 2014 (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:
  • 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

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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756651

Contacts
Contact: Richard Reznichek, MD 3102222724 rreznichek@dhs.lacounty.gov

Locations
United States, California
Urology Clinic, Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Sponsors and Collaborators
Richard C Reznichek, MD
Depomed
Investigators
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: October 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antidiarrheals
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 21, 2014