EVENDOL Scale Validation for at Term New-born

NCT02819076 | Completed DMC

• 1 other identifier: EVENDOL
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 2

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

Conditions

Analgesia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Painless Children

30 children

Other: pain scale

Painful Children

70 children

Other: pain scale

Interventions

pain scale OTHER

Painful Children; Painless Children

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (2)

Hôpital Armand Trousseau

Paris, 75014, France

Location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

• 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.

  PMID: 40487028 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Walter Elisabeth, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: June 13, 2014
• Primary Completion: December 31, 2019
• Study Completion: August 20, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

FR (2)