Observe the analgesia effect and tolerance of IV injected ketamineduring painful bedsore, ulcer or vascular wound care (bandages,cleansing) for hospitalized patients in palliative care units.

Phase 1

• Conditions: Patients’ palliative care for bedsores, ulcers or vascular wounds, which are general characteristics of the patient population that will be included: usually elderly, undernourished and of multiple pathologies.; MedDRA version: 18.0Level: HLGTClassification code 10047079Term: Vascular injuriesSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 18.0Level: PTClassification code 10045285Term: UlcerSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 18.0Level: LLTClassification code 10036651Term: Pressure soreSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.0Level: PTClassification code 10059513Term: Palliative careSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0Level: PTClassification code 10040943Term: Skin ulcerSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-000202-20-FR
• Lead Sponsor: Groupement des Hôpitaux de l’Institut Catholique de Lille (GHICL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-19
• Last Update Posted: 23 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Patients of age (=18 years old), hospitalized in palliative care units
-Conscious or presenting disturbed consciousness but for whom the Rudkin score is = 4 (eyes closed, response to light tactical stimulation)
-For whom a palliative care is acted
-No matter the progression and prognostic status
-After the information is given to the patient (with the notification form given) and the written consent form is retrieved and when the state of cognition and vigilance allows it. In case of cognitive and consciousness disturbance, after informing and retrieving the written consent form from the patient’s trusted person, or a relative by default, for patients under guardianship after being informed and giving a consent form written by the legal representative.
-Evened out on an analgesia level, without care
-Who has not received ketamine for 60 days before inclusion no matter the indications
-For whom bedsore, ulcer or vascular injuries have appeared and continue to be painful despite the administration of opioid bolus with the painful evaluation regarding the visual analogic scale (EVA) = 5/10, or regarding the evaluation of the Algoplus pain behavior scale = 2, or for whom the opioid treatment cannot be administered due to the presence of adverse side effects (drowsiness, confusion, nausea, vomiting, respiratory depression…)
-And for whom caring under Entonox (a medical analgesic gas which is a mix of nitrous oxide and oxygen) is inefficient or not compatible.
-Lack of easy venous access
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Contraindication of Ketamine in case of anesthesia (AMM) : allergy, porphyria
-Late stage heart failure
-Intracranious hypertension
-Acute heart attack phase
-Unstable psychosis
-Presence of agitation
-Pregnant woman
-Patient with no affiliation to a social security system
-Contraindication of Midazolam: known hypersensitivity to benzodiazepines or any other know excipient of the product, acute respiratory depression

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified