Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures
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.
|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|
- 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:
- baseline pain score at admission, when the subject checks in,
- upon entry of the cystoscope into the urethral meatus,
2. and thirty minutes after the cystoscopic procedure has been completed.
- 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.
|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)|
Subjects will receive 100 mcg intranasal fentanyl in 0.1 mL solution.
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.
Sodium Chloride 0.9% intranasal spray
Other Name: normal saline
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|United States, California|
|Harbor UCLA Medical Center Urology Clinic|
|Torrance, California, United States, 90502|
|Principal Investigator:||Richard Reznichek, MD||University of California, Los Angeles|