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

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

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 Overview

• Status: Completed
• Conditions: Gastrostomy; Breakthrough Pain; Upper Aerodigestive Tract Neoplasms
• Intervention / Treatment: Drug: Fentanyl; Drug: Morphine Sulfate; Drug: Morphine Sulfate placebo; Procedure: Gastrostomy; Drug: Fentanyl placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nancy, France
    • Service ORL - CHU NANCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fentanyl; 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; Other Names: PECFENT®; Drug: Morphine Sulfate placebo; Procedure: Gastrostomy
PLACEBO_COMPARATOR: Morphine Sulfate; 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; Other Names: ORAMORPH®; Procedure: Gastrostomy; Drug: Fentanyl placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Patrice GALLET, Service ORL - CHU NANCY - France

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2015
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (ESTIMATE): August 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Head and Neck Neoplasms; Breakthrough Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Morphine
• Other Study ID Numbers: 2014-003352-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO