Pressure Ulcer Clinical Trial
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
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.
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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