Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU
Condition: Pain
Study type: Interventional

Summary: 
      Pain in hospitalized patients has received increasing attention, however due to its
      subjective nature, it has defied objective, quantitative measurements. If a patient is able
      to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS)
      or plain numeric scales.When a patient is unable to communicate, a method that would allow
      the caregiver to continuously monitor patients' pain and alert the provider that the patient
      may be in pain would be quite useful. The Pain Monitor uses a novel measurement technique of
      analyzing changes in skin conductance that can be used in patients who are unable to provide
      a subjective pain score. This study will compare the relationship between the measurements
      taken by the PainMonitor and pain scores given by communicative patients to evaluate the
      safety and efficacy of this monitor during planned, routine procedures.
    

Detailed description: 
      Although pain must be assessed to be treated, it has been challenging to obtain consistent,
      objective, and quantifiable measurements. The best methods currently available are subjective
      scales communicated by the patient such as standardized sentences, visual analog scales
      (VAS), or plain numeric scales. When a patient is unable to communicate, methods used to
      monitor pain are inadequate. A device that provides an objective assessment of pain in these
      patients would alert the patient's caregivers that the patient may be in pain and analgesic
      treatment is indicated.

      Various methods (Evans et al, 2013; Kantor, 2014; Isnardon, 2013) have been proposed to
      monitor patients' reactions to nociceptive stimulation such as:

        -  changes in heart rate or blood pressure

        -  changes in microcirculation

        -  pupillometry

        -  EEG

        -  Auditory or somatosensory evoked potentials All of these methods have been found
           lacking, mostly due to a lack of specificity for pain. Pupillometry is not suitable for
           long periods of measurement and is sensitive to concomitant treatment (e.g. opioids).

      Galvanometry has the potential to provide specific information related to pain in patients
      who are unable to communicate.

      Since sweat glands are the only organs controlled solely by the sympathetic nervous system,
      there is a reasonable chance that the use of galvanometry can provide a reliable means of
      assessing pain. There are numerous papers on this topic; searching in PUBmed on the key words
      "pain" and "skin conductance" results in more than 250 papers (selected references are
      included in the list below). The PainMonitor system uses galvanometry to monitor changes in
      skin conductance responses per sec mirroring the number of bursts in the skin sympathetic
      nerves. This creates a warning for caregivers to assess the potential that the patient is in
      pain.
    

Intervention name(s): Skin Conductance Monitor
Intervention type(s): Device
Other intervention name(s): monitors skin conductance values
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other