Suffering, PhysicalTAMALOUNCT03145454
Objective Markers of Pain Perception in Pediatric Emergency
A study testing electroencephalography helmet, dermal electrode and blood pressure sensors in people with Suffering, Physical, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief rests on the oral communication of the young patient, who does not always able to it (difficult to verbalize, fear of the hospital, problem mental development ...). Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Suffering, Physical
- What is being tested?
- electroencephalography helmet, dermal electrode and blood pressure sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2017to 17 Jul 2018
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Requiring one or more non-complex sutures in department of pediatric emergency
- Affiliate or beneficiary of social security (parents)
- Signature of consent (parents)
Who cannot join
- Historic of cardiovascular diseases (arterial hypertension, etc), renal or metabolic syndrome (diabetes etc.), psychiatric (depression, etc.) or neurological (epilepsy seizure, etc.)
- Trouble of heart rhythm
- Allergy at conductive gel for electrode
- Sutures requiring a general anesthesia
- Contraindication at the Xylocaine and/or Paracetamol
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Saint Etienne
Saint-Etienne, 42055
About this study
Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief rests on the oral communication of the young patient, who does not always able to it (difficult to verbalize, fear of the hospital, problem mental development ...). There is no way in which pain can be apprehended objectively, immediately and effectively. To advance our knowledge of this problem, several approaches have been studied as from functional magnetic resonance imaging (fMRI), electroencephalography (EEG), or from autonomic parameters. However, all these approaches have their limitations: although fMRI presents interesting performances, it allows only a retrospective analysis, and cannot adapt to the clinical context of the young patient for example. EEG-based approaches and autonomic parameters show interesting results but suffer from perfectible sensitivity to muscle activation for EEG whereas the vegetative parameters to stress. In this context, our working hypothesis considers that the search for markers of painful perception must be based on a neurophysiological approach, based on the combined analysis of the EEG and autonomic responses in real time. The aim of this work is to study (1) the cortical (EEG) and autonomic (cardiovascular, skin, pupillary) responses induced by sutures in children who can communicate their pain according to whether they cause pain or not.
- Conditions
- Suffering, Physical
- Being tested
- electroencephalography helmet, dermal electrode, blood pressure sensors, Pupillometry glasses, Holter
- Keywords
- Pain, children, emergency, electroencephalography, heart rate, skin conductance, pupillary diameter
- Medical subject headings
- Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalography helmetDevice
electroencephalography helmet with twelve electrodes will be performed during surgical gesture to determine the pain of child.
dermal electrodeDevice
dermal electrode on the back of the hand will be performed during surgical gesture to determine the pain of child.
blood pressure sensorsDevice
blood pressure sensors on the finger will be performed during surgical gesture to determine the pain of child.
Pupillometry glassesDevice
Pupillometry glasses will be performed during surgical gesture to determine the pain of child.
HolterDevice
Three electrodes electrocardiography on the chest will be performed during surgical gesture to determine the heart rate variability.
| Study group | Role | What they receive |
|---|---|---|
| Pain detection | Experimental | Electroencephalographical responses will be collected during surgical gesture by different intervention: electroencephalography helmet, dermal electrode, blood pressure sensors, pupillometry glasses and Holter. Receives: Device: electroencephalography helmet; Device: dermal electrode; Device: blood pressure sensors; Device: Pupillometry glasses; Device: Holter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of alpha spectral power
Compare measures of alpha spectra power according to electroencephalography helmet and electrode electrocardiography results.
Measured: During the surgical gesture
Secondary outcomes (3)
Rate of spectral power low and high frequency
Rate of spectral power low and high frequency according to heart frequency variability result.
Measured: During the surgical gesture
Amplitude of the dermal responsiveness
Compare amplitude of the dermal responsiveness according to dermal electrode result.
Measured: During the surgical gesture
Amplitude of the pupillary diameter
Compare amplitude of the pupillary diameter according to pupillometry glasses result.
Measured: During the surgical gesture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start4 May 2017
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suffering, PhysicalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues PATURAL, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint EtienneFlorian CHOUCHOU, PhD, Study chair, SAINT-ETIENNE UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145454
- Sponsor's protocol ID
- 1608198
- Other IDs
- ANSM
- Acronym
- TAMALOU
- Status last verified
- Oct 2019
- First submitted
- 5 May 2017
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Markers of Pain Perception in Pediatric Emergency
- ClinicalTrials.gov ID
- NCT03145454
- Acronym / sponsor ID
- TAMALOU / 1608198
- Conditions
- Suffering, Physical
- Keywords
- Pain, children, emergency, electroencephalography, heart rate, skin conductance, pupillary diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 9 May 2017 (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.
Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief rests on the oral communication of the young patient, who does not always able to it (difficult to verbalize, fear of the hospital, problem mental development ...). There is no way in which pain can be apprehended objectively, immediately and effectively. To advance our knowledge of this problem, several approaches have been studied as from functional magnetic resonance imaging (fMRI), electroencephalography (EEG), or from autonomic parameters. However, all these approaches have their limitations: although fMRI presents interesting performances, it allows only a retrospective analysis, and cannot adapt to the clinical context of the young patient for example. EEG-based approaches and autonomic parameters show interesting results but suffer from perfectible sensitivity to muscle activation for EEG whereas the vegetative parameters to stress. In this context, our working hypothesis considers that the search for markers of painful perception must be based on a neurophysiological approach, based on the combined analysis of the EEG and autonomic responses in real time. The aim of this work is to study (1) the cortical (EEG) and autonomic (cardiovascular, skin, pupillary) responses induced by sutures in children who can communicate their pain according to whether they cause pain or not.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain detection | Experimental | Device: electroencephalography helmet, Device: dermal electrode, Device: blood pressure sensors, Device: Pupillometry glasses, Device: HolterElectroencephalographical responses will be collected during surgical gesture by different intervention: electroencephalography helmet, dermal electrode, blood pressure sensors, pupillometry glasses and Holter. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Requiring one or more non-complex sutures in department of pediatric emergency
- Affiliate or beneficiary of social security (parents)
- Signature of consent (parents)
Key exclusion criteria (5 listed)
- Historic of cardiovascular diseases (arterial hypertension, etc), renal or metabolic syndrome (diabetes etc.), psychiatric (depression, etc.) or neurological (epilepsy seizure, etc.)
- Trouble of heart rhythm
- Allergy at conductive gel for electrode
- Sutures requiring a general anesthesia
- Contraindication at the Xylocaine and/or Paracetamol
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 |
|---|---|---|
| electroencephalography helmetelectroencephalography helmet with twelve electrodes will be performed during surgical gesture to determine the pain of child. | Device | Pain detection |
| dermal electrodedermal electrode on the back of the hand will be performed during surgical gesture to determine the pain of child. | Device | Pain detection |
| blood pressure sensorsblood pressure sensors on the finger will be performed during surgical gesture to determine the pain of child. | Device | Pain detection |
| Pupillometry glassesPupillometry glasses will be performed during surgical gesture to determine the pain of child. | Device | Pain detection |
| HolterThree electrodes electrocardiography on the chest will be performed during surgical gesture to determine the heart rate variability. | Device | Pain detection |
Primary outcome
Measure of alpha spectral power
Time frame: During the surgical gesture
Compare measures of alpha spectra power according to electroencephalography helmet and electrode electrocardiography results.
3 secondary outcomes
Rate of spectral power low and high frequency
Time frame: During the surgical gesture
Amplitude of the dermal responsiveness
Time frame: During the surgical gesture
Amplitude of the pupillary diameter
Time frame: During the surgical gesture
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 22 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Hugues PATURAL, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Florian CHOUCHOU, PhD study chair
SAINT-ETIENNE UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalography helmet, dermal electrode and blood pressure sensors in people with Suffering, Physical, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 inclusion and 5 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 22 Oct 2019. 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 France. 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?
Measure of alpha spectral power (time frame: During the surgical gesture). 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 22 Oct 2019.