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Epidemiology of Painful Procedures in Neonates
Not Recruiting
Trial ID: NCT01346813
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:
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
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
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:
- None
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305