Status:
COMPLETED
Functional Near Infrared Spectroscopy to Detect Pain in Young Children Under General Anesthesia
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Pain
Eligibility:
All Genders
1-16 years
Brief Summary
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 opti...
Detailed Description
Pain is a subjective feeling, and an objective measure of pain is needed to obtain improved clinical management and safe outcomes of pain treatment. At present, there is a lack of specific physiologic...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04362423
Start Date
August 1 2014
End Date
September 1 2015
Last Update
September 2 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229