A Phase 4 interventional study of Fentanyl and Morphine Sulfate in Gastrostomy, Breakthrough Pain and Upper Aerodigestive Tract Neoplasms, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by Central Hospital, Nancy, France · Phase 4, Interventional, and Supportive care
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:
Secondary purposes are to compare easiness of 2 treatments and their adverse effects.
Exclusion Criteria:
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
Drug: Fentanyl · Drug: Morphine Sulfate placebo · Procedure: 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
Drug: Morphine Sulfate · Drug: Fentanyl placebo · Procedure: Gastrostomy
Also known as: PECFENT®
Also known as: ORAMORPH®
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
Plan to share: No
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Central Hospital, Nancy, France