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Ketamine and Refractory Painful Care in a Palliative Unit (KETAREF)

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ClinicalTrials.gov Identifier: NCT02587130
Recruitment Status : Recruiting
First Posted : October 27, 2015
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

Brief Summary:

Pain is one of the major symptoms in palliative care units and often is very difficult to treat, being considered as a refractory pain.

There are different causes of refractory pain: pain due to bed sores and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain due to traumatological injuries, pain associated with a long-term bed confinement, etc.

The investigators propose a prospective study to estimate the effect and the tolerance to a subcutaneous bolus of ketamine administered for the treatment of refractory pain due to the care of bedsores, ulcers and vascular wounds in patients hospitalized in palliative care units.


Condition or disease Intervention/treatment Phase
Intractable Pain Intensive Care Pressure Ulcer Pain Management Drug: Ketamine Phase 4

Detailed Description:

Patients in palliative care units have serious and incurable conditions and are in the sickness' late or final stages. This is why the relief of their symptoms is a priority for their medical care, being pain one of the major symptoms.

In this context, the idea of treating various types of pain such as pain due to bed sore and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, etc. was raised.

French Ministry of Health's 2010 recommends the use of ketamine to treat refractory pain after the failure of usual therapeutic treatments (opioids, Nitrous oxide and oxygen (also known as MEOPA)). This treatment is then used in association with midazolam (0.01 to 0.05 mg/kg) to prevent hallucinating effects.

However, the intravenous treatment is often the alternative and this choice is justified by the study population's characteristics (usually elderly patients, multi-pathologic, etc) and by the invasive way of treatment used with a repeated central and peripheral venous catheters which is contrary to the primary objective of patient comfort.

To the investigators' knowledge, no randomised study has ever been done regarding the use of ketamine to treat refractory pain administered subcutaneously.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect and Tolerance of a Ketamine Subcutaneous Bolus, During Painful Care of Refractory Bed Sores, Ulcers and Vascular Wounds in a Palliative Care Unit
Actual Study Start Date : May 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: communicating and none-communicating patients
20 communicating patients (evaluated with the visual analogue pain scale (VAS)) and 20 none-communicating patients or patients presenting cognitive disturbance or vigilance (evaluated with the Algoplus scale)
Drug: Ketamine
ketamine administered in bolus by subcutaneous injection




Primary Outcome Measures :
  1. Change from Baseline in Pain Score on the Visual Analog Scale or Algoplus after subcutaneous bolus of Ketamine [ Time Frame: 2 hours ]
    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 are not adapted (Entonox, in cases of disturbed consciousness) or for whom side effects are unbearable (drowsiness, confusion, nausea, vomiting, respiratory depression…). Two kind of scores will be analyzed (EVA and Algoplus).


Secondary Outcome Measures :
  1. Number of secondary side effects after administration of a sub-cutaneous ketamine's bolus [ Time Frame: 2 hours ]

    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 neuroleptic 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

  2. Ketamine dosage administered in sub-cutaneous bolus before painful caring [ Time Frame: 2 hours ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of ≥18 years old, hospitalized in palliative care units
  • Conscious or presenting altered/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

Exclusion Criteria:

  • Contraindication of Ketamine in case of anesthesia (AMM) : allergy, porphyria
  • Late stage heart failure
  • Intracranial 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587130


Contacts
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Contact: Amélie Lansiaux, MD, PhD lansiaux.amelie@ghicl.net
Contact: Mélane Hamez, Med monitor hamez.Melanie@ghicl.net

Locations
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France
GHICL Recruiting
Lomme, France, 59462
Contact: Amelie Lansiaux, MD, PhD    00 33 3.20.22.57.41    lansiaux.amelie@ghicl.net   
Contact: Melanie Hamez    00 33 3.20.22.57.31    hamez.melanie@ghicl.net   
Sponsors and Collaborators
Lille Catholic University
Investigators
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Principal Investigator: Marie Danel Delerue, MD Groupment des Hôpitaux de l'Institut Catholique de Lille

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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02587130     History of Changes
Other Study ID Numbers: RC-P0041
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: October 2018

Keywords provided by Lille Catholic University:
intractable pain
pressure ulcer
bed sore
palliative medicine
ketamine
pain management

Additional relevant MeSH terms:
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Ketamine
Pressure Ulcer
Ulcer
Pain, Intractable
Pathologic Processes
Skin Ulcer
Skin Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action