EVENDOL Scale Validation for at Term New-born

Status Completed

Clinical Trial 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

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Analgesia

Clinical Trial Details

NCT number	NCT02819076
Study type	Observational
Source	Groupe Hospitalier Paris Saint Joseph
Contact
Status	Completed
Phase
Start date	June 13, 2014
Completion date	August 20, 2021

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05534230` - Dexmedetomidine for Pain Reduction in CABG	N/A
Recruiting	`NCT06275698` - HONEY for the Treatment of POst-Tonsillectomy Pain	N/A
Recruiting	`NCT04436224` - Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation	Phase 4
Not yet recruiting	`NCT04548323` - Hypoalgesic Effects of Walking and Running Imagined
Completed	`NCT06054945` - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed	`NCT04394481` - Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery	Phase 4
Completed	`NCT04690647` - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.	N/A
Completed	`NCT05034601` - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure	N/A
Completed	`NCT03740815` - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection	N/A
Recruiting	`NCT05454202` - Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Recruiting	`NCT04554186` - Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.	N/A
Suspended	`NCT04860635` - Safety of F14 Following Total Knee Replacement	Phase 2/Phase 3
Not yet recruiting	`NCT06393777` - Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion	N/A
Not yet recruiting	`NCT04519463` - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing	Early Phase 1
Completed	`NCT02916342` - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks	Phase 4
Completed	`NCT03206554` - Local Infiltration Analgesia in Total Knee Arthroplasty	Phase 2
Not yet recruiting	`NCT02549118` - Tenoxicam for Intrapartum Analgesia	Phase 2
Not yet recruiting	`NCT02190760` - Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.	N/A
Completed	`NCT01789606` - Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet	Phase 3
Completed	`NCT01299584` - ULTIVA Post Marketing Surveillance	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.