EVENDOL Scale Validation for at Term New-born

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

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Other: pain scale

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 Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Hôpital Armand Trousseau
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Groupe Hospitalier Paris Saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This scale appears suitable for evaluation of the newborn at term pregnancy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Painless Children; 30 children	Other: pain scale
Painful Children; 70 children	Other: pain scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of change in EVENDOL scale	0 minute, 45 minutes then 90 minutes
Assessment of change in EDIN (Pain and Discomfort Scale Newborn) scale	0 minute, 45 minutes then 90 minutes
Assessment of change in NFCS (Neonatal Facial Coding System) scale	0 minute, 45 minutes then 90 minutes

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: WALTER Elisabeth, MD, Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2014
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): August 20, 2021

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EVENDOL