Innovative Approaches to Assessment of Pain Control and Sedation in the NICU

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.

Inclusion Criteria:

- All patients will be admitted to the NICU, and having a post-menstrual age of >28
weeks. Participants will be divided into four groups according to the following
criteria:

Group A

- Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal
atresia treatment);

- Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade

Group B

- Plan for major surgery anticipated to cause pain and agitation (i.e. bowel surgery);

- Patients who are not anticipated to receive acute post-surgical neuromuscular blockade

Group C Plan for minor surgery anticipated to cause pain and agitation (i.e. hernia
repair);

Group D No plan for surgery

Exclusion Criteria:

- Confirmed or suspected clinical seizures

- Metabolic abnormalities or inborn error of metabolism

- Skin abrasions or wounds located at the site of research sensor placement i.e. scalp,
which interfere with the application of electrodes