Clinical trial NCT02869321: Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy
Official title: Evaluation of Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrostomy
Breakthrough Pain
Upper Aerodigestive Tract Neoplasms
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intensity of breakthrough pain during the gastrostomy
timeFrame: during gastrostomy
measure: Intensity of pain following the gastrostomy
timeFrame: 15 min after gastrostomy
measure: Intensity of pain following the gastrostomy
timeFrame: 30 min after gastrostomy
measure: Intensity of pain following the gastrostomy
timeFrame: 1 hour after gastrostomy
measure: Intensity of pain following the gastrostomy
timeFrame: 2 hours after gastrostomy
measure: Intensity of pain following the gastrostomy
timeFrame: 3 hours after gastrostomy
measure: Intensity of pain following the gastrostomy
timeFrame: 4 hours after gastrostomy
measure: Intensity of pain following the gastrostomy
timeFrame: 6 hours after gastrostomy
measure: Intensity of pain following the gastrostomy
timeFrame: 12 hours after gastrostomy
measure: Necessity of a second analgesic treatment after gastrostomy
timeFrame: up to 12 hours from gastrostomy
Secondary outcomes:
measure: Evaluation of satisfaction of patient with analgesic efficacy
timeFrame: up to 1 day from gastrostomy
measure: Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments
timeFrame: up to 1 day from gastrostomy
measure: Compliance of times of administration of treatments with the procedure
timeFrame: day 0
measure: Comparison of adverse effects of administered drugs
timeFrame: up to 24 hours post gastrostomy
Other outcomes:
Locations:
city: Nancy
country: France
facility: Service ORL - CHU NANCY
Study officials:
affiliation: Service ORL - CHU NANCY - France
name: Patrice GALLET
role: PRINCIPAL_INVESTIGATOR
References: