The EVENDOL Pain Scale Validation for Acute Non-Procedural Neonatal Pain in Term Neonates: Reliability and Validity in Maternity Wards.

The assessment of acute non-procedural pain in term neonates in maternity wards is challenging due to the difficulty in selecting an appropriate scale and the time-consuming nature of the process. This can lead to inadequate neonatal pain management. To validate the EValuation ENfant DOuLeur (EVENDOL) pain scale for acute non-procedural pain in term neonates in maternity units by comparing it with the Echelle Douleur et Inconfort du Nouveau-né (EDIN) used as a reference. We hypothesized that EVENDOL would be equivalent to EDIN in assessing acute non-procedural neonatal pain, with better appearance. Prospective multicentric non-interventional open study. Term neonates over 37 weeks' gestation in the delivery room and postnatal care units, with or without acute non-procedural pain, before and after analgesia. Cronbach's α coefficient, intraclass correlation (ICC), and correlation between EVENDOL and EDIN scores, documented by the researchers and the caregivers at rest and mobilization, before and after oral paracetamol, were measured. Ninety-one neonates were included: 48 (51%) had pain and 43 (47%) had no pain. Before analgesia, the Cronbach coefficient was above 0.80, the ICC (25th-75th interquartile ranges [IQ]) were 0.84 (0.77-0.89) and 0.90 (0.85-0.93) at rest and mobilization, respectively. Seventeen patients received oral acetaminophen and were re-assessed. Psychometric values remained good after analgesia (Cronbach coefficient above 0.80, ICC [IQ]: 0.65 [0.26-0.85] and 0.76 [0.45-0.91]) at rest and mobilization, respectively. The feasibility and ease of use were better for EVENDOL for researchers and caregivers. EVENDOL is suitable for the assessment of acute non-procedural neonatal pain for term neonates in the maternity wards. ClinicalTrials.gov identifier: NCT02819076, registered in June 2016 as EVENDOL scale validation for at term newborn.