EVENDOL Scale Validation for at Term New-born

Analgesia Clinical Trial

Official title:

EVENDOL Scale Validation for at Term New-born

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819076
• Other study ID #: EVENDOL
• Status: Completed
• Start date: June 13, 2014
• Est. completion date: August 20, 2021

Study information

• Verified date: August 2021
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 20, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Other:
• pain scale

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France
France	Hôpital Armand Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of change in EVENDOL scale		0 minute, 45 minutes then 90 minutes
Primary	Assessment of change in EDIN (Pain and Discomfort Scale Newborn) scale		0 minute, 45 minutes then 90 minutes
Primary	Assessment of change in NFCS (Neonatal Facial Coding System) scale		0 minute, 45 minutes then 90 minutes