Evaluation of Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intensity of pain following the gastrostomy
研究概览
简要总结
Patients with Head & Neck Squamous Cell Carcinoma often need a gastrostomy. It can be performed with a radiological approach. This procedure is usually not performed under general anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric insufflation and incision of the abdominal wall. Standard analgesic treatments are usually not well-fitted due to onset of action or route of administration. An alternative solution could be fentanyl nasal spray, a treatment with a fast onset of action and with easy use allowing repetition if needed, during the procedure.
The purpose of this study is to compare analgesic efficacy of nasal instillation of PECFENT® to usually administered morphinic analgesic treatment with fast onset of action (ORAMORPH®), in radiologic percutaneous gastrostomy tube placement:
- during the procedure
- following the procedure (measured by Visual Analog Scale (VAS) for Pain at 15 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 12 hours after procedure).
Secondary purposes are to compare easiness of 2 treatments and their adverse effects.
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
- •Patient care for cancer of the upper aerodigestive tract (except sinonasal)
- •> 18, all weights, all sexes
- •Under balanced background opioid treatment since longer than 7 days (VAS < 5)
- •Needing a radiologic gastrostomy under local anesthesia
- •Informed consent
- •Affiliation to social security plan
- •Preliminary medical examination
排除标准
- •Non balanced morphinic treatment : modification of analgesic treatment during 7 previous days
- •Radiotherapy of nasal fossae/sinus
- •Technical impossibility or contraindication to PECFENT®, ORAMORPH® and associated drugs
- •Impossibility of pain evaluation by patient
- •Belonging to protected class: pregnant or breastfeeding woman, person deprived of liberty for judiciary or administrative decision, under-18, person under legal protection or incapable of giving consent, person in life-and-death emergency incapable of giving a preliminary consent
研究组 & 干预措施
Fentanyl
Administration of Morphine Sulfate Placebo and Fentanyl
- Morphine Sulfate Placebo: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy
- Fentanyl: nasal spray solution, 100 µg pulverisation, 15 min before gastrostomy, if not efficacy second dose after 15 min during gastrostomy
Administration 1+2 if pain after 4 hours from gastrostomy
干预措施: Fentanyl (Drug)
Fentanyl
Administration of Morphine Sulfate Placebo and Fentanyl
- Morphine Sulfate Placebo: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy
- Fentanyl: nasal spray solution, 100 µg pulverisation, 15 min before gastrostomy, if not efficacy second dose after 15 min during gastrostomy
Administration 1+2 if pain after 4 hours from gastrostomy
干预措施: Morphine Sulfate placebo (Drug)
Fentanyl
Administration of Morphine Sulfate Placebo and Fentanyl
- Morphine Sulfate Placebo: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy
- Fentanyl: nasal spray solution, 100 µg pulverisation, 15 min before gastrostomy, if not efficacy second dose after 15 min during gastrostomy
Administration 1+2 if pain after 4 hours from gastrostomy
干预措施: Gastrostomy (Procedure)
Morphine Sulfate
Administration of Morphine Sulfate and Fentanyl Placebo
- Morphine Sulfate: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy
- Fentanyl Placebo: nasal spray solution, 100 µg pulverisation, 15 min before gastrostomy, if not efficacy second dose after 15 min during gastrostomy
Administration 1+2 if pain after 4 hours from gastrostomy
干预措施: Morphine Sulfate (Drug)
Morphine Sulfate
Administration of Morphine Sulfate and Fentanyl Placebo
- Morphine Sulfate: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy
- Fentanyl Placebo: nasal spray solution, 100 µg pulverisation, 15 min before gastrostomy, if not efficacy second dose after 15 min during gastrostomy
Administration 1+2 if pain after 4 hours from gastrostomy
干预措施: Fentanyl placebo (Drug)
Morphine Sulfate
Administration of Morphine Sulfate and Fentanyl Placebo
- Morphine Sulfate: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy
- Fentanyl Placebo: nasal spray solution, 100 µg pulverisation, 15 min before gastrostomy, if not efficacy second dose after 15 min during gastrostomy
Administration 1+2 if pain after 4 hours from gastrostomy
干预措施: Gastrostomy (Procedure)
结局指标
主要结局
Intensity of pain following the gastrostomy
时间窗: 12 hours after gastrostomy
Pain measured by VAS
Necessity of a second analgesic treatment after gastrostomy
时间窗: up to 12 hours from gastrostomy
in case of Pain VAS \>4
Intensity of breakthrough pain during the gastrostomy
时间窗: during gastrostomy
Pain measured by VAS
次要结局
- Evaluation of satisfaction of patient with analgesic efficacy(up to 1 day from gastrostomy)
- Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments(up to 1 day from gastrostomy)
- Compliance of times of administration of treatments with the procedure(day 0)
- Comparison of adverse effects of administered drugs(up to 24 hours post gastrostomy)