NCT03057782

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Hour – 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DEVICE	Waveguard (TM) EEG cap	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.
DEVICE	Micro Movement Sensor	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.
DEVICE	Pico Movement Sensor	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.
DEVICE	QS Piezostimulator	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.
DEVICE	tactileTM sensory evaluator	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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2017-02-20
• Last updated: 2022-09-15

Locations

1 site across 1 country: United States