Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy (ANTALGIP)
Gastrostomy, Breakthrough Pain, Upper Aerodigestive Tract Neoplasms
About this trial
This is an interventional supportive care trial for Gastrostomy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Service ORL - CHU NANCY
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Fentanyl
Morphine Sulfate
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
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