Clinical trial NCT02819076: EVENDOL Scale Validation for at Term New-born
Official title: EVENDOL Scale Validation for at Term New-born
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 91
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This scale appears suitable for evaluation of the newborn at term pregnancy.

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Prematurity: newborn \<37 SA
* Children in intensive care or intensive care unit
* Children in vital distress
* Major malformation syndrome
* Non-Francophone Parents

Primary outcomes:
measure: Assessment of change in EVENDOL scale
timeFrame: 0 minute, 45 minutes then 90 minutes
measure: Assessment of change in EDIN (Pain and Discomfort Scale Newborn) scale
timeFrame: 0 minute, 45 minutes then 90 minutes
measure: Assessment of change in NFCS (Neonatal Facial Coding System) scale
timeFrame: 0 minute, 45 minutes then 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
city: Paris
country: France
facility: Hôpital Armand Trousseau
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Walter Elisabeth, MD
role: PRINCIPAL_INVESTIGATOR
References: