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Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01708122
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Richard C Reznichek, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: Fentanyl Drug: saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fentanyl
Subjects will receive either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)
Drug: Fentanyl
100 mcg in 1 mL intranasal spray
Other Name: fentanyl citrate

Placebo Comparator: Placebo
Subjects will receive either 0.5mL or 1 mL of intranasal saline as placebo.
Drug: saline
Sodium Chloride 0.9% intranasal spray
Other Name: normal saline




Primary Outcome Measures :
  1. Pre Procedure 0 - 10 Pain Numerical Rating Scale [ Time Frame: Pre procedure, During procedure, Post procedure ]

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

    1. baseline pain score at admission, when the subject checks in, 2 Upon entry of the cystoscope into the urethral meatus, 3. and thirty minutes after the cystoscopic procedure has been completed.



Secondary Outcome Measures :
  1. O2 Saturation Post Drug Administration [ Time Frame: Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration. ]
    After administration of the study drug, the subject is monitored (oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT01708122


Locations
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United States, California
Harbor UCLA Medical Center Urology Clinic
Torrance, California, United States, 90502
Sponsors and Collaborators
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Investigators
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Principal Investigator: Richard Reznichek, MD University of California, Los Angeles
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Responsible Party: Richard C Reznichek, MD, Medical Doctor, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT01708122    
Other Study ID Numbers: 13623-01
UL1TR000124 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2012    Key Record Dates
Results First Posted: August 20, 2015
Last Update Posted: August 20, 2015
Last Verified: July 2015
Keywords provided by Richard C Reznichek, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:
Intranasal fentanyl
Cystoscopy
Additional relevant MeSH terms:
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Fentanyl
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