A Randomized Trial to Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain in Cancer Patients in the Emergency Department Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Non-inferiority of Fentanyl Nasal Spray Versus Intravenous Opioids in the Change in the Numeric Rating Scale (NRS) Pain Intensity Score at One Hour, Starting From the Time of Drug Delivery (Treatment Initiation).
研究概览
简要总结
The goal of this clinical research study is to compare fentanyl nasal spray with a standard drug given by vein (hydromorphone hydrochloride) to help reduce pain related to cancer in patients coming to the emergency department.
详细描述
Study Groups and Drug Administration:
If participant agrees to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal chance of being in either group:
- If participant is in Group 1, they will receive the fentanyl nasal spray. The study staff will help participant use the nasal spray.
- If participant is in Group 2, the emergency center nurse will give them the hydromorphone hydrochloride by vein.
Study Procedures:
Participant will stay in the emergency department for at least 4 hours and will be monitored after receiving fentanyl or hydromorphone hydrochloride. During this time, participant will be asked about their pain and any side effects they may be having every 15 minutes for 2 hours and then every 30 minutes for another 2 hours. The study staff will also monitor participant's vital signs, and ask them a few more questions at the end of the study.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients with severe pain (i.e., >=7 on NRS, see Table 1) already on opioid therapy for one week or longer, at least 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg of oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.
- •Ability to give informed consent before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •Ability and willingness to communicate the intensity of pain using NRS at the frequency dictated by the protocol
排除标准
- •Patients with a history of chronic active hepatitis, cirrhosis or hepatic encephalopathy
- •Inability to give informed consent
- •Known or suspected hypersensitivity or intolerance to fentanyl or hydromorphone or excipients in the study medications
- •Patients with sinusitis, obstruction of nasal passages, nasopharyngeal cancer, paranasal sinus malignancies, or any conditions in the nasopharyngeal anatomical area that may affect the absorption of fentanyl nasal spray.
- •Females who are pregnant, breast-feeding or intending to become pregnant. This exclusion criterion will be assessed by questioning the patient about the pregnancy status, breast-feeding status, the intent to become pregnant, the menopausal status, and the date of the last menstrual period.
- •Females of child-bearing potential, who are not using adequate contraceptive measures (including condoms, birth control pills, intrauterine devices, contraceptive implants, or other US FDA-approved contraceptives)
- •Previous participation in randomization in this trial
- •Has taken oral immediate release opioids within 4 hours prior to arrival.
研究组 & 干预措施
Fentanyl Nasal Spray
Fentanyl nasal spray 100 mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study.
干预措施: Fentanyl Nasal Spray (Drug)
Fentanyl Nasal Spray
Fentanyl nasal spray 100 mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study.
干预措施: Phone Call (Behavioral)
Hydromorphone Hydrochloride
Hydromorphone hydrochloride 1.5 mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study.
干预措施: Hydromorphone Hydrochloride (Drug)
Hydromorphone Hydrochloride
Hydromorphone hydrochloride 1.5 mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study.
干预措施: Phone Call (Behavioral)
结局指标
主要结局
Non-inferiority of Fentanyl Nasal Spray Versus Intravenous Opioids in the Change in the Numeric Rating Scale (NRS) Pain Intensity Score at One Hour, Starting From the Time of Drug Delivery (Treatment Initiation).
时间窗: Baseline, One hour post time of drug delivery/treatment initiation
The median change in Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain) from randomization, estimate of treatment initiation, to one hour post-treatment calculated for both treatment arms.
次要结局
- Number of Participants With Change in Numeric Rating Scale (NRS) Pain Intensity Score(One (1) hour after treatment start.)