Clinical trial NCT03057782: Innovative Approaches to Assessment of Pain Control and Sedation in the NICU
Official title: Innovative Approaches to Assessment of Pain Control and Sedation in the NICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: Pain
Sedation
Surgery
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Noxious Stimuli Results
timeFrame: Up to 1 year
Secondary outcomes:
measure: Resting State Results
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Laura Cornelissen, PhD
role: PRINCIPAL_INVESTIGATOR
References: