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NCT Number: NCT02819076

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

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Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph, Paris, Île-de-France Region, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pain scale

Other

Primary outcomes

  1. Assessment of change in EVENDOL scale

    Time frame: 0 minute, 45 minutes then 90 minutes

  2. Assessment of change in EDIN (Pain and Discomfort Scale Newborn) scale

    Time frame: 0 minute, 45 minutes then 90 minutes

  3. Assessment of change in NFCS (Neonatal Facial Coding System) scale

    Time frame: 0 minute, 45 minutes then 90 minutes

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2021
First posted
Jun 30, 2016
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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