Last reviewed · How we verify
NCT02819076
EVENDOL Scale Validation for at Term New-born
trial testing pain scale in Analgesia in 91 participants. Completed in 20 August 2021.
31 December 2019
Quick facts
| Lead sponsor | Fondation Hôpital Saint-Joseph |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 91 |
| Start date | 13 June 2014 |
| Primary completion | 31 December 2019 |
| Estimated completion | 20 August 2021 |
| Sites | 2 locations across France |
Drugs / interventions tested
- pain scale
Conditions studied
- Analgesia — all drugs for Analgesia →
Sponsor
Fondation Hôpital Saint-Joseph — full company profile →
Who can join
Adults 0 Days to 28 Days, any sex, with Analgesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The EVENDOL Pain Scale Validation for Acute Non-Procedural Neonatal Pain in Term Neonates: Reliability and Validity in Maternity Wards.
Calamy L, Fournier-Charrière E, Martret P, Cimerman P, et al · · 2025 · PMID 40487028 · DOI 10.1002/pne2.70008
Verify or expand the search:
- PubMed search for NCT02819076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of pain scale
Trials testing the same drug.
- NCT05623449 — Teleconsultations Hypnosis Sessions for Patients with Peripheral Chronic Neuropathic Pain · NA · completed
- NCT03001843 — Ketamine vs Hydromorphone · Phase 4 · completed
Other recruiting trials for Analgesia
Currently open trials in the same condition.
- NCT07249827 — A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guid · Phase 2 · recruiting
- NCT07250230 — Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Un · NA · recruiting
- NCT07337629 — Single Dose Preemptive Paracetamol or Ibuprofen Before Septrorhinoplasty on Intra- and Postoperative Opioid Consumption. · recruiting
- NCT07310953 — Clinical Utility of the Numerical Verbal Scale (NVS) and the Pain and Functional Activity Scale (PFAS) in the Management · NA · recruiting
- NCT06869967 — Evaluation of Postoperative Pain Control in Ear Surgery · NA · recruiting
Other Fondation Hôpital Saint-Joseph trials
Trials by the same sponsor.
- NCT07512960 — Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization · Phase 3 · not yet recruiting
- NCT07512908 — Study of Factors Influencing the Dynamics of Colonisation and Decolonisation of the Digestive Tract by Clostridioides Di · NA · not yet recruiting
- NCT07512830 — Evaluation of the Benefits of Hypnosis During Transoesophageal Echocardiography · NA · recruiting
- NCT07348081 — Real World Evidence to Assess the Value of a Digital Care Coordination and Monitoring Program for Supporting Caregivers · NA · recruiting
- NCT07086612 — Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Transverse Orthodontic Deficiency in Children · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02819076 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondation Hôpital Saint-Joseph
- Last refreshed: 23 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02819076.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing