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

NCT02869321 | Completed Phase 4 DMC

• 1 other identifier: 2014-003352-32
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrostomy; Breakthrough Pain; Upper Aerodigestive Tract Neoplasms

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• Evaluation of satisfaction of patient with analgesic efficacy

  up to 1 day from gastrostomy

• Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments

  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

Study Arms (2)

Fentanyl

EXPERIMENTAL

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

Morphine Sulfate

PLACEBO COMPARATOR

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

Interventions

Fentanyl DRUG

Also known as: PECFENT®

Fentanyl

Morphine Sulfate DRUG

Also known as: ORAMORPH®

Morphine Sulfate

Fentanyl placebo DRUG

Morphine Sulfate

Morphine Sulfate placebo DRUG

Fentanyl

Gastrostomy PROCEDURE

Fentanyl; Morphine Sulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Service ORL - CHU NANCY

Nancy, France

Location

MeSH Terms

Conditions

Breakthrough Pain; Head and Neck Neoplasms

Interventions

Fentanyl; Morphine; Gastrostomy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Digestive System Surgical Procedures; Surgical Procedures, Operative; Ostomy

Study Officials

• Patrice GALLET

  Service ORL - CHU NANCY - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 16, 2016
• Study Start: May 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 13, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)