Breakthrough Pain, Gastrostomy, Upper Aerodigestive Tract Neoplasms
Conditions
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.
Interventions
DRUGFentanyl
DRUGMorphine Sulfate
DRUGFentanyl placebo
DRUGMorphine Sulfate placebo
PROCEDUREGastrostomy
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of breakthrough pain during the gastrostomy | during gastrostomy | Pain measured by VAS |
| Intensity of pain following the gastrostomy | 15 min 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of satisfaction of patient with analgesic efficacy | up to 1 day from gastrostomy | Questionnaire |
| Comparison of adverse effects of administered drugs | up to 24 hours post gastrostomy | — |
| 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 | — |
Countries
France
Outcome results
None listed