Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 13, 2015
First Posted Date  ICMJE October 27, 2015
Last Update Posted Date November 21, 2018
Actual Study Start Date  ICMJE May 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02587130 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine and Refractory Painful Care in a Palliative Unit
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Intractable Pain
  • Intensive Care
  • Pressure Ulcer
  • Pain Management
Intervention  ICMJE Drug: Ketamine
ketamine administered in bolus by subcutaneous injection
Study Arms  ICMJE 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)
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amélie Lansiaux, MD, PhD lansiaux.amelie@ghicl.net
Contact: Mélane Hamez, Med monitor hamez.Melanie@ghicl.net
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02587130
Other Study ID Numbers  ICMJE RC-P0041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lille Catholic University
Study Sponsor  ICMJE Lille Catholic University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Danel Delerue, MD Groupment des Hôpitaux de l'Institut Catholique de Lille
PRS Account Lille Catholic University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP