Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy
- Conditions
- GastrostomyUpper Aerodigestive Tract NeoplasmsBreakthrough Pain
- Interventions
- Procedure: Gastrostomy
- Registration Number
- NCT02869321
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Morphine Sulfate Fentanyl placebo Administration of Morphine Sulfate and Fentanyl Placebo 1. Morphine Sulfate: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy + 2. 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 Fentanyl Fentanyl Administration of Morphine Sulfate Placebo and Fentanyl 1. Morphine Sulfate Placebo: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy + 2. 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 Fentanyl Gastrostomy Administration of Morphine Sulfate Placebo and Fentanyl 1. Morphine Sulfate Placebo: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy + 2. 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 Fentanyl Morphine Sulfate placebo Administration of Morphine Sulfate Placebo and Fentanyl 1. Morphine Sulfate Placebo: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy + 2. 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 Morphine Sulfate Gastrostomy Administration of Morphine Sulfate and Fentanyl Placebo 1. Morphine Sulfate: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy + 2. 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 Morphine Sulfate Morphine Sulfate Administration of Morphine Sulfate and Fentanyl Placebo 1. Morphine Sulfate: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy + 2. 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
- Primary Outcome Measures
Name Time Method Intensity of pain following the gastrostomy 12 hours after gastrostomy Pain measured by VAS
Necessity of a second analgesic treatment after gastrostomy up to 12 hours from gastrostomy in case of Pain VAS \>4
Intensity of breakthrough pain during the gastrostomy during gastrostomy Pain measured by VAS
- Secondary Outcome Measures
Name Time Method Evaluation of satisfaction of patient with analgesic efficacy up to 1 day from gastrostomy Questionnaire
Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments up to 1 day from gastrostomy Questionnaire
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
Trial Locations
- Locations (1)
Service ORL - CHU NANCY
🇫🇷Nancy, France
Service ORL - CHU NANCY🇫🇷Nancy, France