Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard C Reznichek, MD, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT01708122
First received: March 30, 2012
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to assess the efficacy of intranasally-administrated fentanyl spray 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 pain. In this study, an additional medicine (fentanyl) is used to reduce pain that occurs during and after the above procedure.


Condition Intervention Phase
Pain
Drug: Fentanyl
Drug: saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Prospective, Randomized, Double Blind Study Comparing the Efficacy and Safety of Fentanyl Nasal Spray to Placebo as an Analgesic, in Patients Undergoing Outpatient Cystoscopic Procedures

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 0 - 10 Pain Numerical Rating Scale [ Time Frame: Pre, during and after procedure. ] [ Designated as safety issue: No ]

    The NRS pain assessment (0 = no pain to 10 = worst possible pain) is recorded three times as outlined below:

    1. baseline pain score at admission, when the subject checks in,
    2. upon entry of the cystoscope into the urethral meatus,

    2. and thirty minutes after the cystoscopic procedure has been completed.



Secondary Outcome Measures:
  • O2 Saturation. [ Time Frame: Baseline, and every 15 minutes until 3 hours post drug-administration. ] [ Designated as safety issue: Yes ]
    After administration of the study drug, the subject is monitored (pulse rate, blood pressure, respiratory rate and oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation. O2 saturation is recorded every 15 minutes.


Estimated Enrollment: 24
Study Start Date: May 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fentanyl
Subjects will receive 100 mcg intranasal fentanyl in 0.1 mL solution.
Drug: Fentanyl
100 mcg in 0.1 mL intranasal spray
Other Name: fentanyl citrate
Placebo Comparator: Placebo
Subjects will receive 0.1 mL of intranasal saline as placebo.
Drug: saline
Sodium Chloride 0.9% intranasal spray
Other Name: normal saline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Urological indications for cystoscopic procedure.

Exclusion Criteria:

  1. History of analgesia abuse or former opioid addiction.
  2. Allergy to fentanyl.
  3. Acute/chronic nasal problems such as rhinitis or sinusitis.
  4. Positive urine pregnancy test / lactation.
  5. Acute bronchial asthma / upper airway obstruction.
  6. Presence of bradycardia or a history of seizures.
  7. Concomitant use of drugs that inhibit CYP3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, MAO inhibitors and verapamil)
  8. 0-10 NRS pain score more than 3 on 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: NCT01708122

Locations
United States, California
Harbor UCLA Medical Center Urology Clinic
Torrance, California, United States, 90502
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Richard Reznichek, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Richard C Reznichek, MD, Medical Doctor, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01708122     History of Changes
Other Study ID Numbers: 13623-01, UL1TR000124
Study First Received: March 30, 2012
Last Updated: October 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Los Angeles Biomedical Research Institute:
Intranasal fentanyl
Cystoscopy

Additional relevant MeSH terms:
Analgesics
Fentanyl
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Central Nervous System Depressants
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 22, 2014