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

NCT ID: NCT02869321

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-05-31

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.

Conditions

Gastrostomy; Breakthrough Pain; Upper Aerodigestive Tract Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

Morphine Sulfate placebo

Intervention Type: DRUG

Gastrostomy

Intervention Type: PROCEDURE

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

Group Type: PLACEBO_COMPARATOR

Morphine Sulfate

Intervention Type: DRUG

Fentanyl placebo

Intervention Type: DRUG

Gastrostomy

Intervention Type: PROCEDURE

Interventions

Fentanyl

Intervention Type: DRUG

Morphine Sulfate

Intervention Type: DRUG

Fentanyl placebo

Intervention Type: DRUG

Morphine Sulfate placebo

Intervention Type: DRUG

Gastrostomy

Intervention Type: PROCEDURE

Other Intervention Names

PECFENT®; ORAMORPH®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrice GALLET

Role: PRINCIPAL_INVESTIGATOR

Service ORL - CHU NANCY - France

Locations

Service ORL - CHU NANCY

Nancy, , France

Countries

France

Other Identifiers

2014-003352-32

Identifier Type: -

Identifier Source: org_study_id