Calamy Lucie, Fournier-Charrière Elisabeth, Martret Patricia, Cimerman Patricia, Boithias Claire, Debillon Thierry, Carbajal Ricardo, Falissard Bruno, Walter-Nicolet Elizabeth
Medicine and Neonatal Intensive Care Unit Saint Joseph Hospital Paris France.
Paediatric Pain Centre Trousseau Hospital, Assistance Publique - Hôpitaux de Paris Paris France.
Paediatr Neonatal Pain. 2025 Jun 6;7(2):e70008. doi: 10.1002/pne2.70008. eCollection 2025 Jun.
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.
由于难以选择合适的评估量表以及评估过程耗时，对产科病房足月新生儿的急性非程序性疼痛进行评估具有挑战性。这可能导致新生儿疼痛管理不足。通过将EValuation ENfant DOuLeur（EVENDOL）疼痛量表与作为参考的新生儿疼痛与不适量表（Echelle Douleur et Inconfort du Nouveau-né，EDIN）进行比较，以验证其在产科病房足月新生儿急性非程序性疼痛评估中的有效性。我们假设EVENDOL在评估急性非程序性新生儿疼痛方面与EDIN等效，且外观更好。前瞻性多中心非干预性开放研究。纳入产房和产后护理单元中孕周超过37周的足月新生儿，无论有无急性非程序性疼痛，在镇痛前后进行评估。测量了研究人员和护理人员在静息和活动状态下，以及口服对乙酰氨基酚前后记录的EVENDOL和EDIN评分之间的克朗巴哈α系数、组内相关系数（ICC）以及相关性。共纳入91例新生儿：48例（51%）有疼痛，43例（47%）无疼痛。镇痛前，克朗巴哈系数高于0.80，静息和活动状态下的ICC（第25至75四分位数间距[IQ]）分别为0.84（0.77 - 0.89）和0.90（0.85 - 0.93）。17例患者接受口服对乙酰氨基酚并重新评估。镇痛后，静息和活动状态下的心理测量值仍然良好（克朗巴哈系数高于0.80，ICC[IQ]分别为0.65[0.26 - 0.85]和0.76[0.45 - 0.91]）。对于研究人员和护理人员而言，EVENDOL的可行性和易用性更好。EVENDOL适用于产科病房足月新生儿急性非程序性疼痛的评估。ClinicalTrials.gov标识符：NCT02819076，于2016年6月注册为足月新生儿EVENDOL量表验证。
