Ignite Creation Date:
2024-05-06 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03449732
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2018-02-22
Brief Title:
Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children A Proof of Concept Trial
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Evaluation of the Pupil Dilation Reflex PDR Using a Pupillary Pain Index PPI Stimulation Protocol in Response to Noxious Stimulation in Anaesthetized Children A Proof of Concept Trial
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PainOR-kids
Brief Summary:
After conduction a pilot study pupillary dilation reflex PDR is measured in response to nociceptive stimulation perioperatively in infants children and adolescents
Detailed Description:
An infrared camera of the video pupillometer measures the pupillary dilation reflex PDR in response to incremental nociceptive stimuli The PDR is a robust reflex even in patients under general anesthesia and may provide a potential evaluation of the autonomous nociceptive circuit American Society of Anesthesiologists ASA classification I or II patients from the age of 28 days till 18 years undergoing elective surgery under general anesthesia are recruited Enrolled patients perioperative undergo PDR measurement at 2 different standardized times before and after opioid administration generated by an inbuilt pupillary pain index PPI protocol PPI as a surrogate for nociception includes noxious stimulations from 10 up to 60 milli ampere mA until pupil dilation is larger than 13 from baseline diameter Therefore no inappropriate high stimulation is executed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None