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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
20
Service ORL - CHU NANCY
Nancy, France
Intensity of breakthrough pain during the gastrostomy
Pain measured by VAS
Time frame: during gastrostomy
Intensity of pain following the gastrostomy
Pain measured by VAS
Time frame: 15 min after gastrostomy
Intensity of pain following the gastrostomy
Pain measured by VAS
Time frame: 30 min after gastrostomy
Intensity of pain following the gastrostomy
Pain measured by VAS
Time frame: 1 hour after gastrostomy
Intensity of pain following the gastrostomy
Pain measured by VAS
Time frame: 2 hours after gastrostomy
Intensity of pain following the gastrostomy
Pain measured by VAS
Time frame: 3 hours after gastrostomy
Intensity of pain following the gastrostomy
Pain measured by VAS
Time frame: 4 hours after gastrostomy
Intensity of pain following the gastrostomy
Pain measured by VAS
Time frame: 6 hours after gastrostomy
Intensity of pain following the gastrostomy
Pain measured by VAS
Time frame: 12 hours after gastrostomy
Necessity of a second analgesic treatment after gastrostomy
in case of Pain VAS \>4
Time frame: up to 12 hours from gastrostomy
Evaluation of satisfaction of patient with analgesic efficacy
Questionnaire
Time frame: up to 1 day from gastrostomy
Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments
Questionnaire
Time frame: up to 1 day from gastrostomy
Compliance of times of administration of treatments with the procedure
Time frame: day 0
Comparison of adverse effects of administered drugs
Time frame: up to 24 hours post gastrostomy
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