- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03449732
Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial (Pain@OR-kids)
May 17, 2022 updated by: Davina Wildemeersch, University Hospital, Antwerp
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Antwerp
-
Edegem, Antwerp, Belgium, 2650
- University hospital Antwerp
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
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)
|
PDR measurement at two standardized times perioperatively:
Other Names:
|
EXPERIMENTAL: PDR measurement group B
Two measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years)
|
PDR measurement at two standardized times perioperatively:
Other Names:
|
EXPERIMENTAL: PDR measurement group C
Two measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years)
|
PDR measurement at two standardized times perioperatively:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stimulation Intensity
Time Frame: During pupil measurements in the perioperative period
|
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
Time Frame: During pupil measurements in the perioperative period
|
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
Time Frame: During PDR measurements
|
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
Time Frame: During PDR measurements
|
Tachycardia as a common used parameter for perioperative nociceptive assessment
|
During PDR measurements
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nathalie Kegels, MD, University Hospital, Antwerp
- Study Chair: Vera Saldien, MD, University Hospital, Antwerp
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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