Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial (Pain@OR-kids)

Antwerp University Hospital (UZA)

Status: Completed

Conditions: Monitoring, Intraoperative; Pain

Treatments: Device: PDR measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT03449732

17/46/519

Details and patient eligibility

About

After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 28 days to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia
• ASA I-II

Exclusion criteria

• History of eye deformity, invasive ophthalmologic surgery
• Known cranial nerve(s) deficit
• Infection of the eye
• Predicted difficult airway management (Paediatric Difficult Airway Guidelines - Difficult Airway Society)
• Chronic opioid use (>3 months)
• Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
• Preoperatively administrated benzodiazepins or antiemetics

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

PDR measurement group A

Experimental group

Description:

Two measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months)

Treatment:

Device: PDR measurement

PDR measurement group B

Experimental group

Description:

Two measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years)

Treatment:

Device: PDR measurement

PDR measurement group C

Experimental group

Description:

Two measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years)

Treatment:

Device: PDR measurement