PROSPECTIVE, RANDOMIZED, DOUBLE BLIND STUDY COMPARING THE EFFICACY AND SAFETY O

Lundquist Institute For Biomedical Innovation At Harbor-Ucla Medical Center, Torrance CA

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Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to assess the efficacy of Nasal Fentanyl spray to decrease the pain during cystoscopy (the passage of 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. We are planning to use an additional medicine (Fentanyl) to reduce pain during and after the above procedure. In this double-blind study, a nasal spray of either the drug (Fentanyl-an opioid analgesic) or placebo (normal saline) will be administered before the procedure. There is a 50% chance that subjects will receive the drug or the placebo. In either case, local Lidocaine jelly will be used as an anesthetic in the urethra. Each subject successfully enrolled in the study will be compensated with $20 after the completion of his/her participation.