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

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ClinicalTrials.gov Identifier: NCT02869321
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Gastrostomy Breakthrough Pain Upper Aerodigestive Tract Neoplasms Drug: Fentanyl Drug: Morphine Sulfate Drug: Fentanyl placebo Drug: Morphine Sulfate placebo Procedure: Gastrostomy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy
Actual Study Start Date : May 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fentanyl

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
Other Name: PECFENT®

Drug: Morphine Sulfate placebo
Procedure: Gastrostomy
Placebo Comparator: Morphine Sulfate

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
Other Name: ORAMORPH®

Drug: Fentanyl placebo
Procedure: Gastrostomy



Primary Outcome Measures :
  1. Intensity of breakthrough pain during the gastrostomy [ Time Frame: during gastrostomy ]
    Pain measured by VAS

  2. Intensity of pain following the gastrostomy [ Time Frame: 15 min after gastrostomy ]
    Pain measured by VAS

  3. Intensity of pain following the gastrostomy [ Time Frame: 30 min after gastrostomy ]
    Pain measured by VAS

  4. Intensity of pain following the gastrostomy [ Time Frame: 1 hour after gastrostomy ]
    Pain measured by VAS

  5. Intensity of pain following the gastrostomy [ Time Frame: 2 hours after gastrostomy ]
    Pain measured by VAS

  6. Intensity of pain following the gastrostomy [ Time Frame: 3 hours after gastrostomy ]
    Pain measured by VAS

  7. Intensity of pain following the gastrostomy [ Time Frame: 4 hours after gastrostomy ]
    Pain measured by VAS

  8. Intensity of pain following the gastrostomy [ Time Frame: 6 hours after gastrostomy ]
    Pain measured by VAS

  9. Intensity of pain following the gastrostomy [ Time Frame: 12 hours after gastrostomy ]
    Pain measured by VAS

  10. Necessity of a second analgesic treatment after gastrostomy [ Time Frame: up to 12 hours from gastrostomy ]
    in case of Pain VAS >4


Secondary Outcome Measures :
  1. Evaluation of satisfaction of patient with analgesic efficacy [ Time Frame: up to 1 day from gastrostomy ]
    Questionnaire

  2. Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments [ Time Frame: up to 1 day from gastrostomy ]
    Questionnaire

  3. Compliance of times of administration of treatments with the procedure [ Time Frame: day 0 ]
  4. Comparison of adverse effects of administered drugs [ Time Frame: up to 24 hours post gastrostomy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869321


Locations
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France
Service ORL - CHU NANCY
Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Patrice GALLET Service ORL - CHU NANCY - France

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02869321    
Other Study ID Numbers: 2014-003352-32
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Breakthrough Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Neoplasms by Site
Neoplasms
Fentanyl
Morphine
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics