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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Central Hospital, Nancy, France

Current Primary Outcome:

  • Intensity of breakthrough pain during the gastrostomy [ Time Frame: during gastrostomy ]
    Pain measured by VAS
  • Intensity of pain following the gastrostomy [ Time Frame: 15 min after gastrostomy ]
    Pain measured by VAS
  • Intensity of pain following the gastrostomy [ Time Frame: 30 min after gastrostomy ]
    Pain measured by VAS
  • Intensity of pain following the gastrostomy [ Time Frame: 1 hour after gastrostomy ]
    Pain measured by VAS
  • Intensity of pain following the gastrostomy [ Time Frame: 2 hours after gastrostomy ]
    Pain measured by VAS
  • Intensity of pain following the gastrostomy [ Time Frame: 3 hours after gastrostomy ]
    Pain measured by VAS
  • Intensity of pain following the gastrostomy [ Time Frame: 4 hours after gastrostomy ]
    Pain measured by VAS
  • Intensity of pain following the gastrostomy [ Time Frame: 6 hours after gastrostomy ]
    Pain measured by VAS
  • Intensity of pain following the gastrostomy [ Time Frame: 12 hours after gastrostomy ]
    Pain measured by VAS
  • Necessity of a second anal

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Evaluation of satisfaction of patient with analgesic efficacy [ Time Frame: up to 1 day from gastrostomy ]
      Questionnaire
    • Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments [ Time Frame: up to 1 day from gastrostomy ]
      Questionnaire
    • Compliance of times of administration of treatments with the procedure [ Time Frame: day 0 ]
    • Comparison of adverse effects of administered drugs [ Time Frame: up to 24 hours post gastrostomy ]


    Original Secondary Outcome: Same as current

    Information By: Central Hospital, Nancy, France

    Dates:
    Date Received: August 8, 2016
    Date Started: May 2015
    Date Completion: May 2018
    Last Updated: August 19, 2016
    Last Verified: August 2016