AnalgesiaNCT02819076
EVENDOL Scale Validation for at Term New-born
An observational study of Analgesia, run by Fondation Hôpital Saint-Joseph at 2 sites in France.
Trial summary
Maternity and neonatology, caregivers are regularly confronted with the pain of the newborn, especially after a birth injury, but it is sometimes difficult ti define. There is not, to our knowledge, any prevalence study of pain in newborn motherhood. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Analgesia
- What is being tested?
- pain scale
- How many people
- 91 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Jun 2014to 20 Aug 2021
- Phase
- Observational
- 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: This scale appears suitable for evaluation of the newborn at term pregnancy.
Who may be able to join
- New born at term (≥ 37 weeks)
- Suspects or without pain
- From 0 to 28 days of life,
- Able to be studied and monitored by the researcher.
Who cannot join
- Prematurity: newborn <37 SA
- Children in intensive care or intensive care unit
- Children in vital distress
- Major malformation syndrome
- Non-Francophone Parents
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Armand Trousseau
Paris, 75014
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Maternity and neonatology, caregivers are regularly confronted with the pain of the newborn, especially after a birth injury, but it is sometimes difficult ti define.
There is not, to our knowledge, any prevalence study of pain in newborn motherhood. The data available are those of the perinatal survey 2010, with the number of operative vaginal deliveries (5.3% of suction, forceps 3.9%, 2.9% spatulas) and the number of extractions the seat (4.7%). These delivery modes can be purveyors of pain.
Read more
At St. Joseph's Hospital, there were in 2013: 259 instrumental deliveries and 90 extractions by headquarters. Fifty five paracetamol bottles were consumed in the layer sequence in 2013, and 15 in the delivery room. But this consumption is a poor reflection of the pain because treatment could be given pain-authenticated (measured with the EDIN scale), and because a bottle is discarded one month after opening.
The scales measuring pain used in the new-born at term based on the assessment of change in behavior; two specific scores of the newborn are used in France: Pain and Discomfort Scale Newborn (EDIN) for prolonged pain and Acute Pain scale Newborn (DAN) for acute pain related to health care.
The EVENDOL scale (Child Pain Evaluation) has been validated for pediatric emergencies in children 0-7 years, as well as pre-hospital, to measure the intensity of pain whether acute or prolonged (8 ). It is easy and fast to use. validation cohorts included a significant proportion of newborns. This scale appears suitable for evaluation of the newborn to term maternity
Read the detailed description
Objectives:
Principal: validation of the instrument "EVENDOL" in the new-born at term.
Secondary:
- EVENDOL is equivalent to EDIN to diagnose the pain of the newborn at term.
- While being faster and easier to dimension.
- EVENDOL preferred by caregivers
Methodology and conduct of the study:
DESIGN: Study of practical evaluation of observational, prospective, multicenter.
Places of study: maternity of Saint Joseph Hospital, and Kremlin Bicetre. A feasibility study is underway, it was started in neonatology Antoine Béclère. Time study: 12 to 18 months Required subjects: 100 patients (1/3 painless children, 2/3 of painful children).
- Conditions
- Analgesia
- Being tested
- pain scale
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain scaleOther
| Study group | Role | What they receive |
|---|---|---|
| Painless Children | 30 children Receives: Other: pain scale | |
| Painful Children | 70 children Receives: Other: pain scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in EVENDOL scale
Measured: 0 minute, 45 minutes then 90 minutes
Assessment of change in EDIN (Pain and Discomfort Scale Newborn) scale
Measured: 0 minute, 45 minutes then 90 minutes
Assessment of change in NFCS (Neonatal Facial Coding System) scale
Measured: 0 minute, 45 minutes then 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start13 Jun 2014
- Primary completion31 Dec 2019
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter Elisabeth, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819076
- Sponsor's protocol ID
- EVENDOL
- Status last verified
- Aug 2021
- First submitted
- 28 Jun 2016
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Calamy L, Fournier-Charriere E, Martret P, Cimerman P, Boithias C, Debillon T, Carbajal R, Falissard B, Walter-Nicolet E. The EVENDOL Pain Scale Validation for Acute Non-Procedural Neonatal Pain in Term Neonates: Reliability and Validity in Maternity Wards. Paediatr Neonatal Pain. 2025 Jun 6;7(2):e70008. doi: 10.1002/pne2.70008. eCollection 2025 Jun.
PubMed 40487028
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVENDOL Scale Validation for at Term New-born
- ClinicalTrials.gov ID
- NCT02819076
- Acronym / sponsor ID
- EVENDOL
- Conditions
- Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 13 Jun 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 30 Jun 2016 (estimated)
- 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.
Maternity and neonatology, caregivers are regularly confronted with the pain of the newborn, especially after a birth injury, but it is sometimes difficult ti define.
There is not, to our knowledge, any prevalence study of pain in newborn motherhood. The data available are those of the perinatal survey 2010, with the number of operative vaginal deliveries (5.3% of suction, forceps 3.9%, 2.9% spatulas) and the number of extractions the seat (4.7%). These delivery modes can be purveyors of pain.
At St. Joseph's Hospital, there were in 2013: 259 instrumental deliveries and 90 extractions by headquarters. Fifty five paracetamol bottles were consumed in the layer sequence in 2013, and 15 in the delivery room. But this consumption is a poor reflection of the pain because treatment could be given pain-authenticated (measured with the EDIN scale), and because a bottle is discarded one month after opening.
The scales measuring pain used in the new-born at term based on the assessment of change in behavior; two specific scores of the newborn are used in France: Pain and Discomfort Scale Newborn (EDIN) for prolonged pain and Acute Pain scale Newborn (DAN) for acute pain related to health care.
The EVENDOL scale (Child Pain Evaluation) has been validated for pediatric emergencies in children 0-7 years, as well as pre-hospital, to measure the intensity of pain whether acute or prolonged (8 ). It is easy and fast to use. validation cohorts included a significant proportion of newborns. This scale appears suitable for evaluation of the newborn to term maternity
Detailed description
Objectives:
Principal: validation of the instrument "EVENDOL" in the new-born at term.
Secondary:
- EVENDOL is equivalent to EDIN to diagnose the pain of the newborn at term.
- While being faster and easier to dimension.
- EVENDOL preferred by caregivers
Methodology and conduct of the study:
DESIGN: Study of practical evaluation of observational, prospective, multicenter.
Places of study: maternity of Saint Joseph Hospital, and Kremlin Bicetre. A feasibility study is underway, it was started in neonatology Antoine Béclère. Time study: 12 to 18 months Required subjects: 100 patients (1/3 painless children, 2/3 of painful children).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Painless Children | – | Other: pain scale30 children |
| Painful Children | – | Other: pain scale70 children |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This scale appears suitable for evaluation of the newborn at term pregnancy.
Key inclusion criteria (4 listed)
- New born at term (≥ 37 weeks)
- Suspects or without pain
- From 0 to 28 days of life,
- Able to be studied and monitored by the researcher.
Key exclusion criteria (5 listed)
- Prematurity: newborn <37 SA
- Children in intensive care or intensive care unit
- Children in vital distress
- Major malformation syndrome
- Non-Francophone Parents
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 |
|---|---|---|
| pain scale | Other | Painful Children, Painless Children |
Primary outcome
Assessment of change in EVENDOL scale
Time frame: 0 minute, 45 minutes then 90 minutes
Assessment of change in EDIN (Pain and Discomfort Scale Newborn) scale
Time frame: 0 minute, 45 minutes then 90 minutes
Assessment of change in NFCS (Neonatal Facial Coding System) scale
Time frame: 0 minute, 45 minutes then 90 minutes
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 23 Aug 2021.
- Derived from this study: PubMed 40487028Calamy L, Fournier-Charriere E, Martret P, Cimerman P, Boithias C, Debillon T, Carbajal R, Falissard B, Walter-Nicolet E. The EVENDOL Pain Scale Validation for Acute Non-Procedural Neonatal Pain in Term Neonates: Reliability and Validity in Maternity Wards. Paediatr Neonatal Pain. 2025 Jun 6;7(2):e70008. doi: 10.1002/pne2.70008. eCollection 2025 Jun.
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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.
Walter Elisabeth, MD principal investigator
Fondation Hôpital Saint-Joseph
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia, run by Fondation Hôpital Saint-Joseph at 2 sites 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 4 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Assessment of change in EVENDOL scale (time frame: 0 minute, 45 minutes then 90 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819076, which also lists 1 linked publication.
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 23 Aug 2021.