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
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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
ketamine administered in bolus by subcutaneous injection
- 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).
- 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.
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
|Contact: Amélie Lansiaux, MD, PhDfirstname.lastname@example.org|
|Contact: Mélane Hamez, Med monitor||hamez.Melanie@ghicl.net|
|Lomme, France, 59462|
|Contact: Amelie Lansiaux, MD, PhD 00 33 184.108.40.206.41 email@example.com|
|Contact: Melanie Hamez 00 33 220.127.116.11.31 firstname.lastname@example.org|
|Principal Investigator:||Marie Danel Delerue, MD||Groupment des Hôpitaux de l'Institut Catholique de Lille|