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

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

Conditions

• Pain, Postoperative

Interventions

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.

Sponsors & Collaborators

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Laura Cornelissen, PhD · Boston Children's Hospital

Eligibility

Min Age

1 Hour

Max Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• United States

Study Locations