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

Boston Children's Hospital

Status: Completed

Conditions: Pain, Postoperative

Treatments: Device: QS Piezostimulator; Device: Pico Movement Sensor; Device: Micro Movement Sensor; Device: Waveguard (TM) EEG cap; Device: tactileTM sensory evaluator

Study type: Observational

Funder types: Other

Identifiers

NCT03057782

IRB-P00022180

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 hour to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 4 patient groups

Group A

Description:

1. Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal atresia treatment); 2. Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade (NMB) The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. These subjects will also receive EMG monitoring. Subjects in this group will also have video recordings that may be used for novel analysis such as subdermal blood flow or micro-movement.

Treatment:

Device: Pico Movement Sensor

Device: tactileTM sensory evaluator

Device: Waveguard (TM) EEG cap

Device: QS Piezostimulator

Device: Micro Movement Sensor

Group B

Description:

1. Plan for major surgery anticipated to cause pain and agitation (i.e. bowel surgery); 2. Patients who are not anticipated to receive acute post-surgical NMB The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. Subjects in this group will also have video recordings that may be used for novel analysis such as sub-dermal blood flow or micro-movement.

Treatment:

Device: Pico Movement Sensor

Device: tactileTM sensory evaluator

Device: Waveguard (TM) EEG cap

Device: QS Piezostimulator

Device: Micro Movement Sensor

Group C

Description:

Plan for minor surgery anticipated to cause pain and agitation (i.e. hernia repair) The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. Subjects in this group will also have video recordings that may be used for novel analysis such as sub-dermal blood flow or micro-movement.

Treatment:

Device: Pico Movement Sensor

Device: tactileTM sensory evaluator

Device: Waveguard (TM) EEG cap

Device: QS Piezostimulator

Device: Micro Movement Sensor

Group D

Description:

No plan for surgery The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. Subjects in this group will also have video recordings that may be used for novel analysis such as sub-dermal blood flow or micro-movement.

Treatment:

Device: Pico Movement Sensor

Device: tactileTM sensory evaluator

Device: Waveguard (TM) EEG cap

Device: QS Piezostimulator

Device: Micro Movement Sensor