Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial
Pain@OR-kids
1 other identifier
interventional
20
1 country
1
Brief Summary
After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Mar 2018
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2018
CompletedFirst Posted
Study publicly available on registry
February 28, 2018
CompletedStudy Start
First participant enrolled
March 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMay 18, 2022
May 1, 2022
3.1 years
February 22, 2018
May 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Stimulation Intensity
Necessary stimulation intensity to dilate the pupil more than 13%
During pupil measurements in the perioperative period
Secondary Outcomes (3)
Pupillary Pain Index score
During pupil measurements in the perioperative period
Blood pressure
During PDR measurements
Heart rate
During PDR measurements
Study Arms (3)
PDR measurement group A
EXPERIMENTALTwo measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months)
PDR measurement group B
EXPERIMENTALTwo measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years)
PDR measurement group C
EXPERIMENTALTwo measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years)
Interventions
PDR measurement at two standardized times perioperatively: 1. Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached 2. Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth
Eligibility Criteria
You may qualify if:
- Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia
- ASA I-II
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital Antwerp
Edegem, Antwerp, 2650, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathalie Kegels, MD
University Hospital, Antwerp
- STUDY CHAIR
Vera Saldien, MD
University Hospital, Antwerp
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
February 22, 2018
First Posted
February 28, 2018
Study Start
March 30, 2018
Primary Completion
April 26, 2021
Study Completion
December 31, 2021
Last Updated
May 18, 2022
Record last verified: 2022-05