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

Gastrostomy Clinical Trial

— ANTALGIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869321
• Other study ID #: 2014-003352-32
• Status: Completed
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breakthrough Pain
• Gastrostomy
• Head and Neck Neoplasms
• Upper Aerodigestive Tract Neoplasms

Intervention

Drug:
• Fentanyl

• Morphine Sulfate

• Fentanyl placebo

• Morphine Sulfate placebo

Procedure:
• Gastrostomy

Locations

Country	Name	City	State
France	Service ORL - CHU NANCY	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of breakthrough pain during the gastrostomy	Pain measured by VAS	during gastrostomy
Primary	Intensity of pain following the gastrostomy	Pain measured by VAS	15 min after gastrostomy
Primary	Intensity of pain following the gastrostomy	Pain measured by VAS	30 min after gastrostomy
Primary	Intensity of pain following the gastrostomy	Pain measured by VAS	1 hour after gastrostomy
Primary	Intensity of pain following the gastrostomy	Pain measured by VAS	2 hours after gastrostomy
Primary	Intensity of pain following the gastrostomy	Pain measured by VAS	3 hours after gastrostomy
Primary	Intensity of pain following the gastrostomy	Pain measured by VAS	4 hours after gastrostomy
Primary	Intensity of pain following the gastrostomy	Pain measured by VAS	6 hours after gastrostomy
Primary	Intensity of pain following the gastrostomy	Pain measured by VAS	12 hours after gastrostomy
Primary	Necessity of a second analgesic treatment after gastrostomy	in case of Pain VAS >4	up to 12 hours from gastrostomy
Secondary	Evaluation of satisfaction of patient with analgesic efficacy	Questionnaire	up to 1 day from gastrostomy
Secondary	Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments	Questionnaire	up to 1 day from gastrostomy
Secondary	Compliance of times of administration of treatments with the procedure		day 0
Secondary	Comparison of adverse effects of administered drugs		up to 24 hours post gastrostomy