courses about pain evaluation and treatment, placement
of COMFORT scales in front of each incubator, and the
construction of a pain management protocol available in
paper and electronic form. However, during a recent
audit on PAD management in our NICU, we found that
the most important objective we needed to reach was
the systematization of PAD evaluation. We observed that
only two thirds of the neonates under invasive ventilatory
assistance had benefited from at least one formalized
evaluation per day; that is, with the use of a
checklist. This situation prompted us to develop a software
module to specifically manage PAD, which was
included in our daily-use computerized physician order
entry (CPOE) system. We chose this tool for two reasons.
First, we assumed that the module would encourage
physicians to become more directly involved in pain
management, because they would have to validate an
algorithm daily to evaluate PAD and adapt analgesic/
sedative treatment, based on the unit protocol. Second,
we assumed that this tool would encourage the nurses
to score the pain objectively, because by doing so they
would be able to adjust the analgesic/sedative doses on
the basis of their evaluation.
The purpose of this study was to evaluate whether the
inclusion of a PAD evaluation module in the NICU
CPOE system would be an effective strategy to improve
PAD evaluation in premature newborns requiring invasive
ventilation.
Methods
This prospective, before-after study was conducted in
the 12-bed NICU of a tertiary care university hospital in
Montpellier, France. The ratio of pediatric nurses to
infants is 1 to 2 and the shift rotation is every 12 hours.
Local protocol for managing pain and discomfort
Since 2002, our NICU staff has followed the protocol
that we collectively developed for managing pain and
discomfort; this protocol can be consulted in paper
form in the NICU protocol binder. A printed version
of the COMFORT scale for evaluating pain and discomfort
is included in all patient charts, and all medical
and paramedical personnel receive training in
pain and discomfort evaluation and management twice
a year.
COMFORT scale
The COMFORT scale assesses several components of
pain and discomfort and has been validated in premature
newborns under ventilation [11,12]. The components
are essentially observable behaviors and variations
in physiological criteria. The sum of the different items
ranges from 8 to 40. Different cutoff or range values for
the COMFORT scale have been proposed or established
to describe the infant’s status in terms of pain and discomfort
[13,14]. On our unit, we follow the recommendations
of the Centre National de Ressources de lutte
contre la douleur (CNED; National Center for Resources
to Combat Pain; http://www.pediadol.org/IMG/pdf/
COMFORT.pdf ). Newborns are assumed to be “painfree
and comfortable” with scores between 18 and 23.
They are considered to be “in pain or uncomfortable”
with scores between 24 and 40, and “excessively sedated”
with scores between 8 and 17. The interrater reliability
of the COMFORT scale was verified when the scale was
introduced on the NICU in 2002, but it was not
repeated before beginning the study.
NICU protocol
The protocol remained the same and was presented to
all staff before each phase of the study. All newborns
under invasive ventilation received an opioid (sufentanil,
starting dose: 0.1 μg/kg/hr) in combination with a
benzodiazepine (midazolam, starting dose: 30 μg/kg/hr).
The efficacy was evaluated every 8 hours by a pediatric
nurse using the COMFORT scale and every 4 hours if a
painful procedure had been performed. The objective
was a score between 18 and 24. For a score >24, the first
step was to determine whether there was a specific
cause, such as product perfusion or respiratory obstruction,
and to improve the environmental conditions,
notably by changing the baby’s position and the respirator
settings if necessary. Then, if the excessively high
COMFORT score was judged to be directly painrelated—for
example, following a painful medical act—a
bolus corresponding to an hourly dose of sufentanil was
administered over 10 min and the hourly dose was
increased by 20% if the score remained elevated after
two boluses. If the excessively high COMFORT score
was judged to be the result of discomfort—for example,
a hyperalert newborn without a recent medical act
or stimulation who seemed to be struggling against the
respirator—the hourly dose of midazolam was increased
by 20%. If the score was <18, we began reducing the
hourly dose of analgesia/sedation by 20% over 8 hours,
usually beginning with the midazolam. All the patients
also were managed according to the Neonatal Individualized
Development Care and Assessment Program used
on our NICU since 2004 [15].
Computerized pain evaluation module
A CPOE system was introduced on our unit in 2001 to
limit the risk of medical errors [16]. The module was
added to the CPOE system in such a way that, each time
the software was run, a specific window opened first.
Every day, this window prompted the physician to order
COMFORT scale assessment at a modifiable frequency
and the adaptation of sufentanil and/or midazolam
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