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

Central Hospital, Nancy, France

Status and phase: Completed; Phase 4

Conditions: Gastrostomy; Upper Aerodigestive Tract Neoplasms; Breakthrough Pain

Treatments: Drug: Morphine Sulfate; Drug: Fentanyl placebo; Procedure: Gastrostomy; Drug: Morphine Sulfate placebo; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT02869321

2014-003352-32

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Fentanyl

Experimental group

Description:

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

Treatment:

Drug: Fentanyl

Procedure: Gastrostomy

Drug: Morphine Sulfate placebo

Morphine Sulfate

Placebo Comparator group

Description:

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

Treatment:

Drug: Fentanyl placebo

Procedure: Gastrostomy

Drug: Morphine Sulfate