Pain Clinical Trial
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
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
STUDY HYPOTHESIS
Principal hypothesis
- The number of painful and stressful procedures performed in the neonate admitted to
intensive care units is still very high but it is lower than in 2005 Pain scores are lower
when procedures are performed with a specific analgesia prior to procedure.
Secondary hypothesis
- The frequency of pre-procedural analgesia is higher than in 2005
- Certain common procedures such as heel sticks and endotracheal intubations are carried
out with a more frequent analgesia than in 2005
- The use of a continuous sedation and analgesia does not induce a reduction in specific
pre-procedural analgesia
- A real-time pain assessment of painful procedures can be carried out in more than 80%
of procedures performed in neonates in intensive care units Pain scores show that
certain procedures which are apparently not very painful may elicit high pain scores in
very sick neonates
- Certain procedures such as nursing care or weighing may induce high pain scores in
neonates who have invasive tubes (endotracheal tubes, thoracic drainage)
- A continuous sedation and analgesia is given to more than 50% of ventilated neonates.
- Certain characteristics of neonates may influence the use of analgesics for painful
procedures. Ex: gender, age, respiratory support
- Certain contextual characteristics or center may influence the use of analgesics for
painful procedures. Ex: day or night, pain referent in the unit, night head nurse,
written pain management guidelines.
- More than 80% of semi-urgent or non-urgent intubations are carried out with the use of
premedication.
- Opioids are the most commonly drugs used for premedication during endotracheal
intubations in neonates
- The assessment of intubating conditions and neonate tolerance show lower scores when
intubations are performed with a premedication considered as "recommended" by the
American Academy of Pediatrics
- The detailed observation of intubations in SMUR and intensive care units will enable
initial validation of a tool assessment
- Too many capillary blood samples by heel sticks are carried out in neonates even in
neonates that have normal values throughout repeated sticks.
- The frequency of blood gas assessments is widely variable among centers
- The frequency of capillary blood glycemia is widely variable among centers
LONG-TERM EFFECTS OF PAIN AND ANALGESIC TREATMENTS
This objective will be assessed by matching the data of the current Epippain study and
another parallel study (Epipage 2)
Principal hypothesis
- After adjusting for the disease severity, neonates that undergo more painful procedures
have a poorer neurological outcome later in infancy.
Secondary hypothesis
- Higher pain scores are associated with a poorer neurological outcome later in infancy
- The use of central analgesics like opioid does not have a negative effect on
neurological outcome later in infancy.
- The potential negative effect of numerous painful procedures during the neonatal period
can be counteracted by the use of analgesics.
METHODOLOGY
This study will be carried out in neonates cared for in two settings: (i) neonatal or
pediatric intensive care units and (ii) the medical regional pediatric transport system
(SMUR) In the intensive care units, this study is designed as a prospective observational
study to collect around-the-clock bedside data on all painful or stressful procedures
performed in neonates admitted to the participating units. All 16 tertiary care centers,
Neonatal Intensive Care Units (NICUs) and Pediatric Intensive Care Units (PICUs) in the
Paris Region will participate. Since this is an observational study no changes in the
standard of care will be carried out. During the first 14 days of admission to the
participating units, prospective data will be collected on all neonatal procedures causing
pain, stress, or discomfort with the corresponding analgesic therapy. A real-time assessment
of pain induced by each procedure will be carried out by unit staff using the DAN scale. A
detailed record of conditions of endotracheal intubations will also be carried out.
Demographic data, type and duration of respiratory support, sedative and analgesic drugs
administered concomitantly or pre-procedure, and conditions related to each procedure (type,
hour of the day, operator, parental presence) will be collected. We'll also record repeat
procedure attempts for procedures requiring more than one attempt before successful
completion. The use of specific pre-procedural analgesia will be noted for each procedure.
If neonates are discharged from the units before 14 days, data collection on painful
procedures will be stopped on the day of discharge.
In the medical regional pediatric transport system (SMUR), neonates transported during the
2-months study period, will have all their procedures recorded in a specific data collection
form. Demographic data, type of respiratory support, sedative and analgesic drugs
administered concomitantly or pre-procedure, and conditions related to each procedure (type,
hour of the day, operator, parental presence) will be collected. We'll also record repeat
procedure attempts for procedures requiring more than one attempt before successful
completion. The use of specific pre-procedural analgesia will be noted for each procedure. A
real-time assessment of pain induced by each procedure will be carried out by unit staff
using the DAN scale. A detailed record of conditions and neonate tolerance of endotracheal
intubations will also be carried out.
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