Epidemiology of Painful Procedures in Neonates (EPIPPAIN)
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Purpose
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:
- 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.
- 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.
- 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.
- 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
- 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
- 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
| Condition |
|---|
|
Newborn Morbidity Pain Procedures Intratracheal Intubation Analgesia Intensive Care Longterm Effects |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Epidémiologie Des Gestes Douloureux ou Stressants Chez Les Nouveau-nés Pris en Charge Dans Les unités de réanimation néonatale et pédiatrique et Par Les équipes de SMUR de la région d'Ile de France |
| Estimated Enrollment: | 1000 |
| Study Start Date: | May 2011 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 45 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
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
Exclusion Criteria:
- None
Contacts and Locations| France | |
| Hôpital Victor Dupouy. Service de réanimation néonatale | |
| Argenteuil, France, 95107 | |
| Hôpital Antoine Béclère. Service de réanimation néonatale | |
| Clamart, France, 92141 | |
| SMUR 92 Clamart | |
| Clamart, France, 92141 | |
| Hôpital Louis Mourier. Service de réanimation néonatale | |
| Colombes, France, 92701 | |
| CHI Créteil. Service de réanimation néonatale | |
| Créteil, France, 94000 | |
| Hôpital du Sud Francilien. Service de réanimation néonatale | |
| Evry, France, 91014 | |
| Hôpital de Bicêtre. Service de réanimation pédiatrique et néonatale | |
| Le Kremlin-Bicêtre, France, 94275 | |
| Hôpital de Meaux. Service de réanimation néonatale | |
| Meaux, France, 77104 | |
| CHI André Grégoire. Service de réanimation néonatale | |
| Montreuil, France, 93100 | |
| SAMU 93 Montreuil | |
| Montreuil, France, 93100 | |
| Hôpital Armand Trousseau. Service de Réanimation Pédiatrique | |
| Paris, France, 75012 | |
| Hôpital Cochin-Port Royal. Service de médecine néonatale | |
| Paris, France, 75014 | |
| Institut de Puériculture et de Périnatalogie. Service de réanimation néonatale | |
| Paris, France, 75014 | |
| Hôpital Necker Enfants Malades. Service de réanimation pédiatrique et néonatale | |
| Paris, France, 75015 | |
| Hôpital Robert Debré. Service de réanimation néonatale | |
| Paris, France, 75019 | |
| SMUR 75 Necker | |
| Paris, France, 75015 | |
| SMUR 75 Robert Debré | |
| Paris, France, 75019 | |
| Centre Hospitalier Intercommunal de Poissy Saint Germain en Laye Service de réanimation néonatale | |
| Poissy, France, 78300 | |
| SAMU 95 Pontoise | |
| Pontoise, France, 95303 | |
| Centre Hospitalier René Dubos. Service de réanimation néonatale | |
| Pontoise, France, 95303 | |
| Hôpital Delafontaine. Service de réanimation néonatale | |
| Saint Denis, France, 93205 | |
| Principal Investigator: | Ricardo Carbajal, MD, PhD | Hôpital Armand Trousseau, Paris, France |
More Information
No publications provided
| Responsible Party: | CARBAJAL, Professor, Hôpital Armand Trousseau |
| ClinicalTrials.gov Identifier: | NCT01346813 History of Changes |
| Other Study ID Numbers: | EPIPPAIN2_IDF |
| Study First Received: | May 2, 2011 |
| Last Updated: | October 24, 2011 |
| Health Authority: | France: Committee for the Protection of Personnes France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé |
Keywords provided by Hôpital Armand Trousseau:
|
Newborns Premature Pain Pain assessment Painful Procedures Stressful Procedures |
Endotracheal Intubation Analgesia Sedation Longterm effects of pain Epidemiology |
ClinicalTrials.gov processed this record on May 19, 2013