Functional Near Infrared Spectroscopy to Detect Pain in Young Children Under General Anesthesia

Completed

Conditions studied: Pain

In brief

This is a three-phase pilot prospective study to develop a devise capable of detecting changes in cortical blood volume and oxygenation due to noxious stimuli. The hypothesis of the study is that optical signal changes corresponding to blood volume and oxygenation will be detected with functional near infrared spectroscopy in the prefrontal cortex of children under general anesthesia in response to peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP).

Key facts

Study ID

NCT04362423

Run by

Children's Hospital Medical Center, Cincinnati

People needed

39

Starts

2014-08-01

Expected to finish

2015-09-01

Last updated by the study team

2020-09-02

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• They are presenting for tethered spinal cord release , posterior fossa decompression, or spine surgery;
• They are between 1 month to 16 years of age;
• Their anesthetic plan includes endotracheal intubation and neuromonitoring;

You may not qualify if…

• Patients with a known history of chronic pain;
• Patients with abnormal frontal lobe brain structure or abnormality of forehead precluding the fNIRS probe securement;
• Patients with a known allergy to fentanyl;
• Patients with unstable hemodynamics.
• Patients with a contraindication to the use of propofol

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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