PainPain@OR-kidsNCT03449732
Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial
A study testing PDR measurement in people with Pain and Monitoring, Intraoperative, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Pain, Monitoring, Intraoperative
- What is being tested?
- PDR measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Mar 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia
- ASA I-II
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.
Read the 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.
- Conditions
- Pain, Monitoring, Intraoperative
- Being tested
- PDR measurement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDR measurementDevice
Also called PPI assessment
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
| Study group | Role | What they receive |
|---|---|---|
| PDR measurement group A | Experimental | Two measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months) Receives: Device: PDR measurement |
| PDR measurement group B | Experimental | Two measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years) Receives: Device: PDR measurement |
| PDR measurement group C | Experimental | Two measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years) Receives: Device: PDR measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulation Intensity
Necessary stimulation intensity to dilate the pupil more than 13%
Measured: During pupil measurements in the perioperative period
Secondary outcomes (3)
Pupillary Pain Index score
Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%
Measured: 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
Measured: During PDR measurements
Heart rate
Tachycardia as a common used parameter for perioperative nociceptive assessment
Measured: During PDR measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start30 Mar 2018
- Primary completion26 Apr 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davina Wildemeersch, University Hospital, Antwerp
- Investigators
- Nathalie Kegels, MD, Principal investigator, University Hospital, AntwerpVera Saldien, MD, Study chair, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449732
- Sponsor's protocol ID
- 17/46/519
- Acronym
- Pain@OR-kids
- Status last verified
- May 2022
- First submitted
- 22 Feb 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03449732
- Acronym / sponsor ID
- Pain@OR-kids / 17/46/519
- Conditions
- Pain, Monitoring, Intraoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PDR measurement group A | Experimental | Device: PDR measurementTwo measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months) |
| PDR measurement group B | Experimental | Device: PDR measurementTwo measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years) |
| PDR measurement group C | Experimental | Device: PDR measurementTwo measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years) |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia
- ASA I-II
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDR measurementAlso: PPI assessmentPDR 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 | Device | PDR measurement group A, PDR measurement group B, PDR measurement group C |
Primary outcome
Stimulation Intensity
Time frame: During pupil measurements in the perioperative period
Necessary stimulation intensity to dilate the pupil more than 13%
3 secondary outcomes
Pupillary Pain Index score
Time frame: During pupil measurements in the perioperative period
Blood pressure
Time frame: During PDR measurements
Heart rate
Time frame: During PDR measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Kegels, MD principal investigator
University Hospital, Antwerp
Vera Saldien, MD study chair
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDR measurement in people with Pain and Monitoring, Intraoperative, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulation Intensity (time frame: During pupil measurements in the perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.