This study showed that adding a PAD module to a NICU CPOE system improved both PAD evaluation and analgesia/sedation dose adaptation on the basis of the scores. The midazolam dosage was increased after module inclusion, whereas the durations of ventilation and NICU stay were not affected.
The evaluation of PAD is mandatory in France and is part of the nursing role (Decree of competence No. 2004–802 of July 29, 2004, regarding professional nursing acts and the exercise of the nursing profession). Yet despite this, PAD evaluation remains inadequate on intensive care units—whether neonatal, pediatric, or adult—with the prevalence of patients evaluated ranging from 40% to 70% [7, 19, 20]. Including a specific module in our CPOE system thus seemed to be a potential means to improve the evaluation rate for our nursing staff. For the physicians, a daily suggestion to validate an algorithm for adapting analgesia/sedation dosages on the basis of COMFORT scores was expected to lead to systematic discussions with the nurses on the PAD of the individual patient. For the nurses, the immediate association of a score with a therapeutic response was expected to reinforce the importance of regular PAD evaluation [21, 22]. Nurses feel supported in performing these evaluations when they know that the physicians are strongly involved . The inclusion of the module improved drug adaptation by the nurses, whether the scores were high or low. However, in both periods, the nurses were less inclined to act when scores were low. This result points to the need to transmit a balanced message on PAD management by also emphasizing the risks associated with excessive sedation and analgesia.
The durations of invasive ventilation and NICU hospitalization and the rate of nosocomial infection remained comparable before and after the intervention. The literature has shown conflicting results regarding the impact of an analgesia/sedation algorithm on the duration of invasive ventilation [24, 25]. Only certain studies on adult patients have demonstrated a shorter ventilation period [21, 23, 26–28] or a benefit in terms of the pneumonia associated with mechanical ventilation . However, the protocols for adult ICUs include daily interruption of analgesia/sedation to determine whether the patient can be extubated [28, 29]. This strategy, which may in itself reduce the time of ventilation, is rarely used in pediatrics  and was not employed on our unit. In any case, the small number of subjects in our study did not permit any conclusions to be drawn regarding this secondary outcome. Moreover, the algorithm for evaluation and management of PAD was the same during the two study periods. We studied only the systematization of this algorithm and not its implementation.
We chose the COMFORT scale over other multidimensional PAD scales, because it has been validated for use in newborns to assess objectively the adequacy of analgesia/sedation and it is widely used [13, 19, 31]. However, as opposed to the situation for adults, no scale is currently able to distinguish pain from discomfort in newborns [32, 33]. This lack of specificity in the COMFORT scale implies a certain degree of subjectivity in the interpretation of scores, and frequent discussions between physicians and nurses are needed to determine the best therapeutic choice as pain and discomfort are managed differently. As noted in the Methods section, we optimized the environmental conditions before proceeding to a therapeutic adaptation of either midazolam if the infant was assessed as “uncomfortable or agitated” or sufentanil if assessed as “hyperalgesic.” It was noteworthy that the more systematized evaluation of PAD, following the addition of the module, led to an increase in the prescription of sedatives and not analgesics. One explanation is that our NICU staff has become very sensitized to pain management since 2002. When a newborn is exposed to a situation likely to generate pain, evaluation and management of the pain is nearly systematic. In contrast, our results indicated that situations of discomfort were underestimated by the nursing staff and that multidimensional scales might help to better sensitize them to discomfort and its management, through medication or other means.
Whether the use of sedation and analgesia is recommended during invasive ventilation in newborns, the use of midazolam remains controversial . Nevertheless, this drug is widely used on French NICUs, and no adverse effect was found at the age of 5 years in a large cohort of premature infants exposed to extended sedation/analgesia compared with an unexposed group .
The limitations of the study include the pre-post design. The CPOE system had been in use on our unit before the study began, and thus randomization with and without a computerized tool was not feasible. We therefore used a simple before–after design for the pain and discomfort module. However, this method is open to criticism and did not allow us to affirm that our results were the exclusive consequence of module introduction. Alternative explanations include unnoticed changes in the patient characteristics at inclusion or in the management protocols on the NICU. The nursing staff turnover was 6% during the study, and we also cannot exclude that some of the “new” nurses had undertaken personal training on pain. Indeed, these nurses were generally young and perhaps more sensitized to pain management. With a short period of observation, only 6 months after module introduction, we cannot assume that the observed changes were sustained over time. The limited number of infants, the monocentric nature of the study, and the specificities of our “homemade” module also are limitations for extrapolating our data to other NICUs. Nevertheless, we believe that our results will serve to encourage reflection on how to improve PAD evaluation in critically ill newborns.