Objective Measurement of Pain Using the Algometer
Condition: Healthy
Study type: Observational

Summary: 
      The development of tools for assessment and management of pain in newborns and children is a
      high priority and represents a significant unmet need. The inadequate treatment of pain and
      the overuse of analgesics can cause harmful consequences for neonates, infants, and children.
      To accomplish successful pain management in children one must first objectively assess pain.
      Thus, to address these critical issues with pain management, the Human Algometer and methods
      are under development by Drs. Julia Finkel and Zena Quezado, Pain Medicine Program (SZI) at
      Children's National Medical Center.
    

Detailed description: 
      It is generally recognized that pain assessment and management in newborns and children is an
      unmet need. According to the American Medical Association, "The pediatric population is at
      risk of inadequate pain management, with age-related factors affecting pain management in
      children. Children are often given minimal or no analgesia for procedures that would
      routinely be treated aggressively in adults. Although much is now known about pain management
      in children, it has not been widely or effectively translated into routine clinical
      practice."1 Although some clinically validated methods exist (e.g. CRIES, PPIP, Faces, etc.),
      no "gold standard" of pain assessment has been adopted in clinical practice. All are hindered
      by ambiguous behavioral correlates to the pain stimuli standards as well as the subjective
      variability inherent in both clinical and parent evaluators 2.

      Other apparatus/methods for pain assessment suffer from similar shortcomings. For example,
      pain tolerance threshold (PTT) and current perception threshold (CPT) determinations both
      rely on verbal response from a patient. Those determinations are subjective and
      semi-quantitative and use electrical stimulation to directly excite both large and small
      diameter sensory nerve fibers. The CPT determination represents the minimum amount of a
      potentially noxious electrical stimulus that can be perceived, while the PTT determination
      represents the maximum amount of noxious electrical stimulation that can be tolerated when
      used as a clinical diagnostic tool. Thus, PTT depends on a subject's verbal response and
      requires patient exposure to aversive electrical stimulation, which causes both undesirable
      discomfort but also elicits the affective component of pain.

      Therefore, the development of tools for assessment and management of pain in newborns and
      children is a high priority and represents a significant unmet medical need. Both
      inadequately treated pain or over administration of analgesics can have deleterious
      physiologic consequences for neonates, infants and children. While a number of methods are in
      use, no "gold standard" for pain assessment exists. (Anand 2007) To accomplish meaningful
      pain management in children one must first be able to objectively assess pain, particularly
      in patients who are (1) non-verbal (e.g. neonates, infants), (2) lacking understanding and
      adequate verbalization skills (e.g. young children, developmentally disabled individuals) and
      (3) patients with compromising neuropathic clinical presentations. To address these critical
      issues with pain management, the Human Algometer and method are under development by Drs.
      Finkel and Quezado from the Pain Medicine Program at the Sheikh Zayed Institute. In brief,
      this device integrates a neurospecific neurostimulation of sensory nerve fibers involved in
      pain response and near infra-red spectroscopy (NIRS) signal acquisition derived from pain
      related hemodynamic changes in the somatosensory cortex. The device has the ability to
      collect data on the NIRS response in the cerebral cortex to noxious stimulation provided by
      the neurostimulation component. Signal processing of data from this trial and subsequent
      trials will result in (1) the detection and optimization of a NIRS signal specific to
      increased neuronal blood flow over the somatosensory cortex (nociceptive response) and the
      frontal cortex (affective component). The individual neurostimulatory and NIRS signal
      acquisition components integrated into this novel device are based in part or whole on
      previously FDA approved devices from Neurotron, Inc. and Covidien plc (former Somanetics
      INVOS ™) respectively.
    

Intervention name(s): Pressure Algometer Testing
Intervention type(s): Device
Other intervention name(s): Wagner FPIX 50™ digital pressure algometer.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults.