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

Primary Purpose

Gastrostomy, Breakthrough Pain, Upper Aerodigestive Tract Neoplasms

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Fentanyl
Morphine Sulfate
Fentanyl placebo
Morphine Sulfate placebo
Gastrostomy
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastrostomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service ORL - CHU NANCY

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fentanyl

Morphine Sulfate

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intensity of breakthrough pain during the gastrostomy
Pain measured by VAS
Intensity of pain following the gastrostomy
Pain measured by VAS
Intensity of pain following the gastrostomy
Pain measured by VAS
Intensity of pain following the gastrostomy
Pain measured by VAS
Intensity of pain following the gastrostomy
Pain measured by VAS
Intensity of pain following the gastrostomy
Pain measured by VAS
Intensity of pain following the gastrostomy
Pain measured by VAS
Intensity of pain following the gastrostomy
Pain measured by VAS
Intensity of pain following the gastrostomy
Pain measured by VAS
Necessity of a second analgesic treatment after gastrostomy
in case of Pain VAS >4

Secondary Outcome Measures

Evaluation of satisfaction of patient with analgesic efficacy
Questionnaire
Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments
Questionnaire
Compliance of times of administration of treatments with the procedure
Comparison of adverse effects of administered drugs

Full Information

First Posted
August 8, 2016
Last Updated
May 10, 2019
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02869321
Brief Title
Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy
Acronym
ANTALGIP
Official Title
Evaluation of Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrostomy, Breakthrough Pain, Upper Aerodigestive Tract Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl
Arm Type
Experimental
Arm Description
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
Arm Title
Morphine Sulfate
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
PECFENT®
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Other Intervention Name(s)
ORAMORPH®
Intervention Type
Drug
Intervention Name(s)
Fentanyl placebo
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate placebo
Intervention Type
Procedure
Intervention Name(s)
Gastrostomy
Primary Outcome Measure Information:
Title
Intensity of breakthrough pain during the gastrostomy
Description
Pain measured by VAS
Time Frame
during gastrostomy
Title
Intensity of pain following the gastrostomy
Description
Pain measured by VAS
Time Frame
15 min after gastrostomy
Title
Intensity of pain following the gastrostomy
Description
Pain measured by VAS
Time Frame
30 min after gastrostomy
Title
Intensity of pain following the gastrostomy
Description
Pain measured by VAS
Time Frame
1 hour after gastrostomy
Title
Intensity of pain following the gastrostomy
Description
Pain measured by VAS
Time Frame
2 hours after gastrostomy
Title
Intensity of pain following the gastrostomy
Description
Pain measured by VAS
Time Frame
3 hours after gastrostomy
Title
Intensity of pain following the gastrostomy
Description
Pain measured by VAS
Time Frame
4 hours after gastrostomy
Title
Intensity of pain following the gastrostomy
Description
Pain measured by VAS
Time Frame
6 hours after gastrostomy
Title
Intensity of pain following the gastrostomy
Description
Pain measured by VAS
Time Frame
12 hours after gastrostomy
Title
Necessity of a second analgesic treatment after gastrostomy
Description
in case of Pain VAS >4
Time Frame
up to 12 hours from gastrostomy
Secondary Outcome Measure Information:
Title
Evaluation of satisfaction of patient with analgesic efficacy
Description
Questionnaire
Time Frame
up to 1 day from gastrostomy
Title
Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments
Description
Questionnaire
Time Frame
up to 1 day from gastrostomy
Title
Compliance of times of administration of treatments with the procedure
Time Frame
day 0
Title
Comparison of adverse effects of administered drugs
Time Frame
up to 24 hours post gastrostomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice GALLET
Organizational Affiliation
Service ORL - CHU NANCY - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service ORL - CHU NANCY
City
Nancy
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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