Ketamine and Refractory Painful Care in a Palliative Unit

NCT02587130 | Terminated Phase 4

• 1 other identifier: RC-P0041
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Intractable Pain; Intensive Care; Pressure Ulcer; Pain Management

Keywords

intractable pain; pressure ulcer; bed sore; palliative medicine; ketamine; pain management

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Pain Score on the Visual Analog Scale or Algoplus after subcutaneous bolus of Ketamine

  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).

  2 hours

Secondary Outcomes (2)

• Number of secondary side effects after administration of a sub-cutaneous ketamine's bolus

  2 hours

• Ketamine dosage administered in sub-cutaneous bolus before painful caring

  2 hours

Study Arms (1)

communicating and none-communicating patients

EXPERIMENTAL

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

Interventions

Ketamine DRUG

ketamine administered in bolus by subcutaneous injection

communicating and none-communicating patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

GHICL

Lomme, 59462, France

Location

MeSH Terms

Conditions

Pain, Intractable; Pressure Ulcer; Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Marie Danel Delerue, MD

  Groupment des Hôpitaux de l'Institut Catholique de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 27, 2015
• Study Start: May 1, 2016
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-02

Locations

FR (1)