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: 18.0 Level: HLGT Classification code 10047079 Term: Vascular injuries System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0 Level: PT Classification code 10045285 Term: Ulcer System Organ Class: 10018065 - General disorders and administration site condit
Conditions
Interventions
Trade Name: KETAMINE PANPHARMA 50 mg/5 ml, solution injectable (I.M.-I.V.)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: KETAMINE
CAS Number: 6740-88-1
Concentration unit: mg/ml mil
Sponsors
Groupement des Hôpitaux de l’Institut Catholique de Lille (GHICL)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the symptomatic effect on pain and the comfort of ketamine’s sub-cutaneous bolus administered to adults hospitalized in palliative units during painful care of vascular wounds, ulcers and bedsores, not eased by opioid or Entonox (a medical analgesic gas which is a mix of nitrous oxide and oxygen) or for whom these treatments aren’t adapted (Entonox, in cases of disturbed consciousness) or for whom side effects are unbearable (drowsiness, confusion, nausea, vomiting, respiratory depression…).;Secondary Objective: •Evaluate the tolerance of the sub-cutaneous administration of ketamine’s bolus, with protocol dosages and with the surveillance of: -Arterial pressure, heart frequency, respiratory frequency, saturation in visual oxygen -The appearance of neurodysleptic symptoms: confusion, perturbation of visual/hearing sensations, humor perturbation, hallucinations, agitation… -Appearance of hypersialorrhea, bronchial cluttering -Presence of nausea or vomiting -Presence of cephalgia or dizziness •Define a ketamine dosage administered in sub-cutaneous bolus, before painful caring in order to obtain the antalgic efficacy thanks to EVA < 3 or Algoplus scale < 2, and in a satisfactory efficacy/tolerance report for patients’ comfort.;Primary end point(s): •Evaluation of pain in different moments or care via the two approved scales : -The visual analogic scale (EVA) for communicative and coherent patients -The behavior Algoplus scale for non-communicative patients or patients with cognitive or consciousness disturbances •The evaluation of the patient’s comfort, by the person caring for the patient via a visual analogic scale at different times of care.;Timepoint(s) of evaluation of this end point: after 3 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Evaluation of the tolerance of treatment via the observation of adverse effects that can arise in: -Vigilance stat (Rudkin score) -Heart frequency and arterial tension -Respiratory frequency and saturation in O2 -Presence of confusion -Presence of psychodysleptic symptoms : disturbance of visual/hearing sensations, humor disturbance, hallucinations, agitation -Presence of hypersialorrhea -Presence of bronchial clotting -Presence of nausea or vomiting -Observation of the appearance of other adverse events •Establishing ketamine sub-cutaneous dosage needed for obtaining an analgesic efficiency defined by EVA < 3 or a Algoplus < 2.;Timepoint(s) of evaluation of this end point: after 3 hours | — |
Countries
France
Contacts
Public ContactCRA
Groupement des Hôpitaux de l’Institut Catholique de Lille (GHICL)
Outcome results
None listed