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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Experimental | Administration of Morphine Sulfate Placebo and Fentanyl
Administration 1+2 if pain after 4 hours from gastrostomy |
|
| Morphine Sulfate | Placebo Comparator | Administration of Morphine Sulfate and Fentanyl Placebo
Administration 1+2 if pain after 4 hours from gastrostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug |
|
| |
| Morphine Sulfate |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of breakthrough pain during the gastrostomy | Pain measured by VAS | during gastrostomy |
| Intensity of pain following the gastrostomy | Pain measured by VAS | 15 min after gastrostomy |
| Intensity of pain following the gastrostomy | Pain measured by VAS | 30 min after gastrostomy |
| Intensity of pain following the gastrostomy | Pain measured by VAS | 1 hour after gastrostomy |
| Intensity of pain following the gastrostomy | Pain measured by VAS | 2 hours after gastrostomy |
| Intensity of pain following the gastrostomy | Pain measured by VAS | 3 hours after gastrostomy |
| Intensity of pain following the gastrostomy | Pain measured by VAS | 4 hours after gastrostomy |
| Intensity of pain following the gastrostomy | Pain measured by VAS | 6 hours after gastrostomy |
| Intensity of pain following the gastrostomy |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of satisfaction of patient with analgesic efficacy | Questionnaire | up to 1 day from gastrostomy |
| Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrice GALLET | Service ORL - CHU NANCY - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service ORL - CHU NANCY | Nancy | France |
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| Drug |
|
|
| Fentanyl placebo | Drug |
|
| Morphine Sulfate placebo | Drug |
|
| Gastrostomy | Procedure |
|
Pain measured by VAS |
| 12 hours after gastrostomy |
| Necessity of a second analgesic treatment after gastrostomy | in case of Pain VAS >4 | up to 12 hours from gastrostomy |
Questionnaire
| up to 1 day from gastrostomy |
| 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 |
| ID | Term |
|---|---|
| D059390 | Breakthrough Pain |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D009020 | Morphine |
| D005774 | Gastrostomy |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010030 | Ostomy |
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