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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 本研究的目的是评估芬太尼鼻腔喷雾剂在膀胱镜检查(通过伸缩仪器进入膀胱以诊断尿血、尿路主诉或任何其他膀胱问题的原因)时减轻疼痛的效果。 目前的标准做法是使用利多卡因凝胶(一种局部麻醉剂)通过尿路给药来润滑和减轻疼痛。我们计划在上述过程中和之后使用一种额外的药物(芬太尼)来减轻疼痛。 在这项双盲研究中，在手术前将给予该药物(芬太尼-阿片类止痛剂)或安慰剂(生理盐水)的鼻腔喷雾。受试者接受药物或安慰剂的可能性为50%。在任何一种情况下，当地的利多卡因果冻都将被用作尿路的麻醉剂。每名成功登记参加研究的受试者在完成参加研究后将获得20美元的补偿。

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.