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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Pre Procedure 0 - 10 Pain Numerical Rating Scale
研究概览
简要总结
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.
详细描述
In this double-blind study, a nasal spray of either the drug (fentanyl -- an opioid analgesic) or placebo (normal saline) is administered before the procedure. There is a 50% chance that patients receive the drug or the placebo. In either case, local Lidocaine jelly is used as an anesthetic in the urethra. Each patient is compensated for time and traveling after the completion of his/her participation.
Patients are asked to arrive between 7 and 11 PM on the evening prior to their procedure for an overnight admission to 5 East ward, on the 5th floor of the Harbor UCLA Medical Center in Torrance, California, United States. Once there, vital signs (blood pressure, pulse, oxygen saturation -- amount of oxygen in the blood, and breathing rate) is checked and an intravenous line is placed. Before, during and after the procedure, patients are asked to rate their pain on a scale of 0 to 10 with 0 being "no pain" and 10 being "the worst pain possible."
Regardless of whether patients are assigned to receive fentanyl or placebo, they receive the standard of care for this cystoscopic procedure.
Once in the cystoscopy room, patients receive the study drug by nasal (into the nose) spray. The study drug is supplied in a pre-filled syringe that contains either 100 mcg of fentanyl or placebo (normal saline with no active medicine in it). Once the study drug is given, the vital signs are closely monitored(checked) until the effect of drug wears off, usually between 2 and 4 hours.
Blood samples are drawn on several occasions. This blood is used to see how much of the study drug (fentanyl or placebo) appears in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urological indications for cystoscopic procedure.
排除标准
- •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.
研究组 & 干预措施
Fentanyl
Subjects will receive either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)
干预措施: Fentanyl (Drug)
Placebo
Subjects will receive either 0.5mL or 1 mL of intranasal saline as placebo.
干预措施: saline (Drug)
结局指标
主要结局
Pre Procedure 0 - 10 Pain Numerical Rating Scale
时间窗: Pre procedure, During procedure, Post procedure
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.
次要结局
- O2 Saturation Post Drug Administration(Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.)
研究者
Richard C Reznichek, MD
Medical Doctor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center