Innovative Approaches to Assessment of Pain Control and Sedation in the NICU
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      It is difficult to assess pain and agitation in the NICU population because for a multitude
      of reasons including the pre-verbal nature of the patient population, the atypical pain
      response of premature infants, and the use of muscle relaxing medications that exclude motor
      response in pain assessments. Current assessment tools are based on physical exam and vital
      signs. The investigators propose to study the role of EEG and palmar conductance (PD) as
      additional tools in the assessment of pain and agitation
    

Detailed description: 
      This is a prospective, non-interventional study designed to assess noxious-specific
      neurophysiologic responses and clinical signs following procedural pain in infants requiring
      hospitalization in the neonatal intensive care unit (NICU) following elective surgery.

      The main goal of the study is to develop a method that reliably quantifies the level of pain
      induced from clinically-required noxious procedures to infants hospitalized in the NICU. This
      method will use measures of neurophysiological, autonomic, and behavioral responses to
      non-noxious and clinically-required noxious stimuli in order to guide the pharmacological
      treatment of NICU patients with analgesic agents, sedatives and/or muscle relaxants.

      The investigators hypothesize that resting state activity and physiological responses to
      noxious and non-noxious stimuli provide a more reliable assessment of the level of pain of
      infants hospitalized in the NICU compared to behavioral-based pain scores.
    

Intervention name(s): Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): The device is an EEG cap - a non-invasive EEG positioning system used to quickly place a large number of surface electrodes in a quick and consistent manner on the head. The device will measure electrophysiological signals from the scalp at the time points in the study listed in the protocol.; This device is not FDA approved. This device is in clinical use for all age groups and used for research purposes by neurologists, physiologists and anesthesiologists. In this study, the device is used to monitor breathing and movement in children; the device is not used for validation purposes.; This device is not FDA approved. This device is in clinical use for all age groups and used for research purposes by neurologists, physiologists and anesthesiologists. In this study, the device is used to monitor respiration rate and gross body movement in children. The device will not be used for validation purposes.; This device is not FDA approved. This device is used for research purposes by neurologists and physiologists. It is a mechanical tactile stimulator for use in functional imaging experiments like MEG, fMRI or EEG. The stimulation is realized by using several different pin matrices. In this study, the device is used to stimulate the children's extremities in order to elicit somatosensory evoked responses.; This device is not FDA approved. This device is used for clinical and research purposes by neurologists and physiologists. It is used to stimulate the children's extremities in order to elicit somatosensory evoked responses.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective, non-interventional study designed to assess neurophysiologic
        responses and clinical signs to noxious and non-noxious stimuli following procedural pain
        in infants requiring NICU care following elective surgery. Simultaneous measures of
        neurophysiological, autonomic and behavioral responses to non-noxious and
        clinically-required noxious stimuli will be collected from patients in the NICU.
      
Keywords: Pain; Sedation; Surgery