Pain Clinical Trial
— EPIPPAINOfficial 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
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. 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. 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. 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. 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. 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. 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
Status | Completed |
Enrollment | 1000 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 45 Weeks |
Eligibility |
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: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Hôpital Victor Dupouy. Service de réanimation néonatale | Argenteuil | |
France | Hôpital Antoine Béclère. Service de réanimation néonatale | Clamart | |
France | SMUR 92 Clamart | Clamart | |
France | Hôpital Louis Mourier. Service de réanimation néonatale | Colombes | |
France | CHI Créteil. Service de réanimation néonatale | Créteil | |
France | Hôpital du Sud Francilien. Service de réanimation néonatale | Evry | |
France | Hôpital de Bicêtre. Service de réanimation pédiatrique et néonatale | Le Kremlin-Bicêtre | |
France | Hôpital de Meaux. Service de réanimation néonatale | Meaux | |
France | CHI André Grégoire. Service de réanimation néonatale | Montreuil | |
France | SAMU 93 Montreuil | Montreuil | |
France | Hôpital Armand Trousseau. Service de Réanimation Pédiatrique | Paris | |
France | Hôpital Cochin-Port Royal. Service de médecine néonatale | Paris | |
France | Hôpital Necker Enfants Malades. Service de réanimation pédiatrique et néonatale | Paris | |
France | Hôpital Robert Debré. Service de réanimation néonatale | Paris | |
France | Institut de Puériculture et de Périnatalogie. Service de réanimation néonatale | Paris | |
France | SMUR 75 Necker | Paris | |
France | SMUR 75 Robert Debré | Paris | |
France | Centre Hospitalier Intercommunal de Poissy Saint Germain en Laye Service de réanimation néonatale | Poissy | |
France | Centre Hospitalier René Dubos. Service de réanimation néonatale | Pontoise | |
France | SAMU 95 Pontoise | Pontoise | |
France | Hôpital Delafontaine. Service de réanimation néonatale | Saint Denis |
Lead Sponsor | Collaborator |
---|---|
Hôpital Armand Trousseau |
France,
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