A Prospective Study Comparing the Efficacy and Safety of 100 mcg and 200 mcg of Intranasal Fentanyl Pectin Spray as an Analgesic in Adult Males Undergoing Outpatient Cystoscopic Procedures
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in pain numeric rating scale
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of intranasally-administrated fentanyl pectin spray (Lazanda®)given 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 local pain. In this study, an additional medicine (Lazanda®) is used to reduce pain that occurs during and after the above procedure.
详细描述
In this prospective study, twenty subjects will be enrolled. The first ten will receive a dose of 100mcg pectin fentanyl nasal spray (Lazanda®). The second ten will receive a dose of 200mcg pectin fentanyl nasal spray (Lazanda®) if the 100mcg was well tolerated in the first ten. In all cases, Lidocaine jelly is used as an local anesthetic in the urethra.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male adult patients scheduled for cystoscopy; additional procedures (e.g. ureteral stent placement, stent exchange, bladder biopsy, retrograde pyelogram) may be included.
排除标准
- •History of analgesic abuse or opioid tolerance
- •Allergy to fentanyl or to any of the components of Lazanda®
- •Acute/chronic nasal problems such as rhinitis or sinusitis
- •Acute bronchial asthma / upper airway obstruction
- •Presence of bradycardia or history of seizures
- •Concomitant use of drugs that inhibit cytochrome P450 isoenzyme 3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, monoamine oxidase inhibitors and verapamil) or exposure to these drugs 30 days prior to placement on the study.
- •Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline)
- •Numeric Rating Scale (NRS) pain score more than 0 at 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
Intranasal Fentanyl 100mcg
fentanyl pectin nasal spray 100mcg
干预措施: Fentanyl pectin (Drug)
Intranasal Fentanyl 200mcg
fentanyl pectin nasal spray 200mcg
干预措施: Fentanyl pectin (Drug)
结局指标
主要结局
Change from baseline in pain numeric rating scale
时间窗: within 3 hours post administration of the drug
The primary endpoint is the worst pain experienced at any time during the procedure. Pain will be assessed using the Numeric Rating Scale (NRS score 0 = no pain to 10 = worst possible pain).
次要结局
- Oxyhemoglobin saturation(Every 5 minutes post administration of the drug until 3 hours)
研究者
Richard C Reznichek, MD
Medical Doctor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center