Epidemiology of Painful Procedures in Neonates

NCT01346813 | Completed

• 1 other identifier: EPIPPAIN2_IDF
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 21

Brief Summary

Sick or premature neonates are exposed to frequent painful and stressful procedures during their stay in neonatal intensive care units. Although neonates do feel pain and may have long term effects induced by painful experiences, prevention and treatment of neonatal pain is far from optimal in many units. An epidemiological study (EPIPPAIN) conducted in neonatal and pediatric intensive care units in France in 2005 showed that painful procedures were extremely frequent and that analgesics treatments varied a lot among units. Since many guidelines have been issued by international scientific societies to manage neonatal pain, one may expect that the prevention and treatment of neonatal pain has improved over the last 6 years. Although awake endotracheal intubations are extremely difficult or impossible in older children or adults, such intubations are still frequently performed without sedation/analgesia in neonates. Recent studies have shown that premedications facilitate intubation conditions and greatly improve neonates tolerance of the procedure. Studies aimed at assessing the risks and benefits of different sedations/analgesia strategies are urgently needed in neonates. We also need a tool to assess at the same time the technical conditions of intubations and the tolerance of the neonate to the procedure so that data from different studies can be compared. The objectives of the present study are:

1. 1.To describe the incidence of painful and stressful procedures performed in the neonate in intensive care units as well as in neonates transported by the medical emergency system (SMUR) of the Ile-de-France region 6 years after the first EPPIPAIN study conducted in the same region and same type of population in order to assess the evolution of practices. The description of painful and stressful procedures will be completed with a real-time around-the-clock assessment of the pain induced by procedures using a validated behavioral pain scale.
2. 2.To link this study with The Epipage study 2 in order to look for associations between the number of painful and stressful procedures and/or analgesic treatments of the neonatal period and the neurological outcome of children that will be followed in the Epipage cohort. The Epipage study is a separate study that will follow for 13 years a cohort of premature neonates recruited in 2011.
3. 3.To describe the incidence of painful or stressful procedures and analgesic treatments in neonates transported by the pediatric emergency system (SMUR) of the Ile-de-France region in France.
4. 4.To obtain initial validity of a tool permitting to assess intubations in neonates. An observational detailed description of endotracheal intubations conditions will be conducted in neonates transported and intubated by SMUR and in neonates intubated in intensive care units
5. 5.To describe continuous sedation and analgesia practices in ventilated neonates in intensive care units. For these neonates, data from medical records will be recovered up to 2 months of admission in intensive care units
6. 6.To describe the frequency of heel sticks for glycemia measurement and blood gazes practices among centers. Relate heel stick practices to the normality or abnormality of glycemia results

Conditions

Newborn Morbidity; Pain; Procedures; Intratracheal Intubation; Analgesia; Intensive Care; Longterm Effects

Keywords

Newborns; Premature; Pain; Pain assessment; Painful Procedures; Stressful Procedures; Endotracheal Intubation; Analgesia; Sedation; Longterm effects of pain; Epidemiology

Eligibility Criteria

• Age: Up to 45 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Two settings: neonatal or pediatric intensive care units and regional pediatric transport system (SMUR). In intensive care units, during the first 14 days of admission prospective data will be collected on all neonatal procedures causing pain, stress, or discomfort with the corresponding analgesic therapy and pain assessment. A detailed record of conditions of endotracheal intubations will also be carried out. In the SMUR, neonates transported during the 2-months study period by all of 5 SMUR will have all their procedures recorded in a specific data collection form. A real-time assessment of pain induced by each procedure will be carried out by staff using the DAN scale. A detailed record of conditions and neonate tolerance of endotracheal intubations will also be carried out.

You may qualify if:

• Intensive care units:
• Neonates admitted to the unit during the 6-week recruitment period
• Age less than 45 post-conceptional weeks
• Regional pediatric transport system (SMUR):
• Neonates transported during the 2-months recruitment period
• Age less than 45 post-conceptional weeks

You may not qualify if:

• None

Sponsors & Collaborators

• Hôpital Armand Trousseau: lead

Study Sites (21)

Hôpital Victor Dupouy. Service de réanimation néonatale

Argenteuil, 95107, France

Location

Hôpital Antoine Béclère. Service de réanimation néonatale

Clamart, 92141, France

Location

SMUR 92 Clamart

Clamart, 92141, France

Location

Hôpital Louis Mourier. Service de réanimation néonatale

Colombes, 92701, France

Location

CHI Créteil. Service de réanimation néonatale

Créteil, 94000, France

Location

Hôpital du Sud Francilien. Service de réanimation néonatale

Évry, 91014, France

Location

Hôpital de Bicêtre. Service de réanimation pédiatrique et néonatale

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital de Meaux. Service de réanimation néonatale

Meaux, 77104, France

Location

CHI André Grégoire. Service de réanimation néonatale

Montreuil, 93100, France

Location

SAMU 93 Montreuil

Montreuil, 93100, France

Location

Hôpital Armand Trousseau. Service de Réanimation Pédiatrique

Paris, 75012, France

Location

Hôpital Cochin-Port Royal. Service de médecine néonatale

Paris, 75014, France

Location

Institut de Puériculture et de Périnatalogie. Service de réanimation néonatale

Paris, 75014, France

Location

Hôpital Necker Enfants Malades. Service de réanimation pédiatrique et néonatale

Paris, 75015, France

Location

SMUR 75 Necker

Paris, 75015, France

Location

Hôpital Robert Debré. Service de réanimation néonatale

Paris, 75019, France

Location

SMUR 75 Robert Debré

Paris, 75019, France

Location

Centre Hospitalier Intercommunal de Poissy Saint Germain en Laye Service de réanimation néonatale

Poissy, 78300, France

Location

Centre Hospitalier René Dubos. Service de réanimation néonatale

Pontoise, 95303, France

Location

SAMU 95 Pontoise

Pontoise, 95303, France

Location

Hôpital Delafontaine. Service de réanimation néonatale

Saint-Denis, 93205, France

Location

Related Publications (2)

• Carbajal R, Lode N, Ayachi A, Chouakri O, Henry-Larzul V, Kessous K, Normand A, Courtois E, Rousseau J, Cimerman P, Chabernaud JL. Premedication practices for tracheal intubation in neonates transported by French medical transport teams: a prospective observational study. BMJ Open. 2019 Nov 14;9(11):e034052. doi: 10.1136/bmjopen-2019-034052.

  PMID: 31727669 DERIVED

• Courtois E, Cimerman P, Dubuche V, Goiset MF, Orfevre C, Lagarde A, Sgaggero B, Guiot C, Goussot M, Huraux E, Nanquette MC, Butel C, Ferreira AM, Lacoste S, Sejourne S, Jolly V, Lajoie G, Maillard V, Guedj R, Chappuy H, Carbajal R. The burden of venipuncture pain in neonatal intensive care units: EPIPPAIN 2, a prospective observational study. Int J Nurs Stud. 2016 May;57:48-59. doi: 10.1016/j.ijnurstu.2016.01.014. Epub 2016 Feb 8.

  PMID: 27045564 DERIVED

MeSH Terms

Conditions

Pain; Agnosia; Premature Birth

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ricardo Carbajal, MD, PhD

  Hôpital Armand Trousseau, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: May 3, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 26, 2011

Record last verified: 2011-10

Locations

FR (21)