A Randomized Controlled Double-Blind Trial of Fentanyl Nasal Spray (Lazanda) Plus Hydromorphone Demand PCA Versus Placebo Nasal Spray Plus Hydromorphone Demand PCA for Treatment of Breakthrough Cancer Pain in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation.
研究概览
简要总结
The goal of this clinical research study is to learn if fentanyl nasal spray can help decrease pain related to cancer when used with other drugs for pain. Researchers also want to know if this drug can help decrease the length of your stay in the Emergency Department.
In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study spray to learn if the study spray has any real effect.
You will also be given intravenous (IV) pain drugs. You will be given these drugs even if you decide not to take part in this study.
详细描述
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to receive either fentanyl nasal spray or a placebo nasal spray. You will have an equal chance of being assigned to either group.
Neither you nor the study staff will know if you are receiving the study spray or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Visit and Study Treatment:
During your stay in the Emergency Department today, the following tests and procedures will be performed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients presenting to the Emergency Department for treatment of acute breakthrough pain who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. (Patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer.)
- •Patients must have severe pain on an 11-point Numeric Rating Scale (NRS 7-10)
- •Breakthrough cancer pain must be of sufficient severity to warrant the use of intravenous opioids in the judgment of the treating emergency physician
- •Age between 18 and 75 years
- •Able to understand the description of the study and give informed consent
- •Patients must be willing to and capable of providing frequent pain assessments for up to 8 hours
- •English-speaking
排除标准
- •Patients will not be approached while they are in acute distress and those exhibiting symptoms (such as dyspnea, uncontrolled nausea/vomiting or vertigo) to such an extent that impairs their ability to understand and evaluate informed consent
- •Patients participating in other clinical trials for pain
- •Patients who are not already tolerant to opioids
- •Patients, who in the judgment of the treating clinician, are suspected to have hepatic or renal failure
- •Patients who are pregnant or lactating
- •Patients with a known allergy or significant reaction to fentanyl, the components of the IN formulation, hydromorphone, or other opioids
- •Patients already on high morphine equivalent daily dose (MEDDs) (>500 mg/day).
研究组 & 干预措施
Fentanyl Nasal Spray + Hydromorphone PCA
Fentanyl 100 mcg nasal spray administered plus hydromorphone PCA. All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.
干预措施: Fentanyl Nasal Spray (Drug)
Fentanyl Nasal Spray + Hydromorphone PCA
Fentanyl 100 mcg nasal spray administered plus hydromorphone PCA. All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.
干预措施: Hydromorphone PCA (Drug)
Placebo Nasal Spray + Hydromorphone PCA
Placebo nasal spray administered plus hydromorphone PCA . All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.
干预措施: Hydromorphone PCA (Drug)
Placebo Nasal Spray + Hydromorphone PCA
Placebo nasal spray administered plus hydromorphone PCA . All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.
干预措施: Placebo Nasal Spray (Other)
结局指标
主要结局
Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation.
时间窗: 4 hours
Primary outcome is total pain relief score (TOTPAR4) at 4 hours after treatment initiation. TOTPAR4 defined as the sum of hourly pain relief scores after baseline to four hours after the first administered dose of Lazanda or placebo. Scores range from -1 (worse pain) to 4 (complete relief). Range of possible TOTPAR4 summed scores is -4 to 16. A TOTPAR4 score greater than or equal to 8 is considered a positive response.
次要结局
未报告次要终点