课题基金 / 基金详情

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

PROSPECTIVE, RANDOMIZED, DOUBLE BLIND STUDY COMPARING THE EFFICACY AND SAFETY O
比较 O 的有效性和安全性的前瞻性、随机、双盲研究
批准号:
8174529
负责人:
RICHARD REZNICHEK
金额:
$0.83万
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-12-01 至 2010-11-30

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中文摘要
翻译
这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者(PI)可能从另一个NIH来源获得了主要资金, 因此可以在其他CRISP条目中表示。所列机构为 研究中心,而研究中心不一定是研究者所在的机构。 本研究的目的是评估芬太尼鼻喷雾剂在膀胱镜检查(将伸缩式仪器插入膀胱,以诊断尿血、泌尿系统疾病或膀胱的任何其他问题)期间减轻疼痛的有效性。 目前的标准做法是使用利多卡因凝胶(局部麻醉剂)通过尿道给予润滑和减轻疼痛。我们计划使用额外的药物(芬太尼)来减轻上述手术期间和之后的疼痛。 在这项双盲研究中,在手术前将给予药物(芬太尼-阿片类镇痛药)或安慰剂(生理盐水)的鼻喷雾剂。受试者接受药物或安慰剂的可能性为50%。在这两种情况下,局部利多卡因凝胶将被用作尿道内的麻醉剂。每例成功入组研究的受试者将在完成参与研究后获得20美元的补偿。
英文摘要
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.
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