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

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

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

Study Overview

• Status: Completed
• Conditions: Pain; Monitoring, Intraoperative
• Intervention / Treatment: Device: PDR measurement

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PDR measurement group A; Two measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months)	Device: PDR measurement; PDR measurement at two standardized times perioperatively: Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached; Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth; Other Names: PPI assessment
EXPERIMENTAL: PDR measurement group B; Two measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years)	Device: PDR measurement; PDR measurement at two standardized times perioperatively: Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached; Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth; Other Names: PPI assessment
EXPERIMENTAL: PDR measurement group C; Two measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years)	Device: PDR measurement; PDR measurement at two standardized times perioperatively: Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached; Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth; Other Names: PPI assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stimulation Intensity	Necessary stimulation intensity to dilate the pupil more than 13%	During pupil measurements in the perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupillary Pain Index score	Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%	During pupil measurements in the perioperative period
Blood pressure	Hypertension as a common used parameter for perioperative nociceptive assessment defined as an increase in systolic blood pressure by >10% of the initial systolic blood pressure	During PDR measurements
Heart rate	Tachycardia as a common used parameter for perioperative nociceptive assessment	During PDR measurements

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Nathalie Kegels, MD, University Hospital, Antwerp; Study Chair: Vera Saldien, MD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2018
• Primary Completion (ACTUAL): April 26, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (ACTUAL): February 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Pupil Disorders; Mydriasis
• Other Study ID Numbers: 17/46/519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No