Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures
This study has been completed.
Information provided by (Responsible Party):
Richard C Reznichek, MD, Los Angeles Biomedical Research Institute
First received: March 30, 2012
Last updated: July 25, 2015
Last verified: July 2015
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
||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
Primary Outcome Measures:
- Pre Procedure 0 - 10 Pain Numerical Rating Scale [ Time Frame: Pre procedure, During procedure, Post procedure ] [ Designated as safety issue: No ]
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:
- O2 Saturation Post Drug Administration [ Time Frame: Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration. ] [ Designated as safety issue: Yes ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
Subjects will receive either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)
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.
Sodium Chloride 0.9% intranasal spray
Other Name: normal saline
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
1. Urological indications for cystoscopic procedure.
- History of analgesia abuse or former opioid addiction.
- Allergy to fentanyl.
- Acute/chronic nasal problems such as rhinitis or sinusitis.
- Positive urine pregnancy test / lactation.
- Acute bronchial asthma / upper airway obstruction.
- Presence of bradycardia or a history of seizures.
- 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)
- 0-10 NRS pain score more than 3 on baseline.
- Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01708122
|Harbor UCLA Medical Center Urology Clinic
|Torrance, California, United States, 90502 |
Los Angeles Biomedical Research Institute
||Richard Reznichek, MD
||University of California, Los Angeles
No publications provided
||Richard C Reznichek, MD, Medical Doctor, Los Angeles Biomedical Research Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 30, 2012
|Results First Received:
||July 25, 2015
||July 25, 2015
||United States: Food and Drug Administration
Keywords provided by Los Angeles Biomedical Research Institute:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 04, 2016
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents