Epidemiology of Painful Procedures in Neonates

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.