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Completed

NCT Number: NCT02869321

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.

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Key information

Conditions

Gastrostomy Breakthrough Pain Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Aerodigestive Tract Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service ORL - CHU NANCY

Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

Other names: PECFENT®

Morphine sulfate

Drug

Other names: ORAMORPH®

Fentanyl placebo

Drug

Morphine Sulfate placebo

Drug

Gastrostomy

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ANTALGIP

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2016
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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