Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy

Study Overview
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Brief Summary
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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: 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.

Official Title
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Evaluation of Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy

Conditions
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Gastrostomy, Breakthrough Pain, Upper Aerodigestive Tract Neoplasms

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Morphine Sulfate
* Drug: Fentanyl placebo
* Drug: Morphine Sulfate placebo
* Procedure: Gastrostomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl<br>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 | Drug: Fentanyl<br> <br> * Other names: PECFENT®;Drug: Morphine Sulfate placebo<br> <br> Procedure: Gastrostomy<br> <br> |
| Placebo Comparator: Morphine Sulfate<br>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 | Drug: Morphine Sulfate<br> <br> * Other names: ORAMORPH®;Drug: Fentanyl placebo<br> <br> Procedure: Gastrostomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |