Sedation and analgesia practices in neonatal intensive care units (EUROPAIN): results from a prospective cohort study

Carbajal, Ricardo; Eriksson, Mats; Courtois, Émilie; Boyle, Elaine M.; Ávila-Álvarez, Alejandro; Andersen, Randi Dovland; Sarafidis, Kosmas; Pölkki, Tarja; Matos, Cristina; Lago, Paola; Papadouri, Thalia; Montalto, Simon Attard; Ilmoja, Mari‐Liis; Simons, Sinno; Tamelienė, Rasa; Overmeire, Bart Van; Berger, Angelika; Dobrzańska, Anna; Schroth, Michael; Bergqvist, Lena; Lagercrantz, Hugo; Anand, K.J.S.

doi:10.1016/s2213-2600(15)00331-8

Cited by 160 publications

(145 citation statements)

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“…The first is the different prevalence of delirium in these populations. In our environment, agitated delirium does not exceed 8% in intubated patients whilst it is greater than 25% in non-intubated patients (6). A second reason is due to the different hazard presented by these patients.…”

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confidence: 75%

Dexmedetomidine, agitated delirium, and “off-label” drugs

2016

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We appreciate the comments by Parker et al. (1) and Knauert et al. (2) concerning our recent manuscript entitled "Dexmedetomidine for the treatment of hyperactive delirium refractory to haloperidol in non-intubated ICU patients: A non-randomized controlled trial" (3). We are agreed with the most of reviewer's considerations. However, we would like to add three reflections that may be interesting for the readers. The first relates to the current position of this alpha-2 agonist on the healthcare market. A second comment intends to respond to some interesting assertions from the reviewers that, in our opinion, could be controversial. The third and final comment is addressed to reflect on the future of the research on intensive care unit (ICU) delirium.The first comment refers to the restricted indications of dexmedetomidine in ICUs setting. This drug was approved in the United States by the Food and Drug Administration (FDA) in late 1999 for use in humans as sedation of initially intubated and mechanically ventilated patients during treatment in an ICU setting, and sedation of nonintubated patients prior to and/or during surgical and other procedures. Subsequently this agent was approved also by the European Medicines Agency (EMA) for the same restricted indications. Consequently, dexmedetomidine has been especially studied for sedation in intubated patients. It has been widely compared with standard ICU intravenous sedation (propofol, midazolam lorazepam...) (4,5). Although dexmedetomidine provided some minor advantages (such as longer adequate sedation level) compared with standard ICU sedatives, the available evidence has shown that its main advantage is the control of delirium symptoms in intubated patients (an indication that was not included by authorizing its use). Although agitated delirium in intubated patients is a major problem, in the non-intubated this problem can be even greater. This is due to two reasons. The first is the different prevalence of delirium in these populations. In our environment, agitated delirium does not exceed 8% in intubated patients whilst it is greater than 25% in non-intubated patients (6). A second reason is due to the different hazard presented by these patients. Agitated delirium in intubated patients is rarely a critical problem because the dangerous agitation can be easily treated with standard sedation (propofol, midazolam lorazepam...). Oppositely, higher risk of respiratory depression limits treatment in non-intubated subjects. We wanted to investigate the problem of agitated delirium in non-intubated patients because it represented one of the main therapeutic challenges in our ICU.Strictly speaking, the treatment of delirium with dexmedetomidine could be seen as an «off-label» indication. Off-label drug use refers to the prescription of licensed drugs for clinical indications or in a manner different from that approved by the regulatory authorities and thus not included in the approved labeling for the agents. Use of drugs for a clinical indication, in a patient po...

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confidence: 75%

Dexmedetomidine, agitated delirium, and “off-label” drugs

2016

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“…However, pain was not evaluated by scoring with a validated pain scale, because the hypothesis was established after recruitment of the sample; instead, the attendants used a combination of physiological and behavioral changes to estimate the pain in patients [10] , which we recognize as a study limitation. This limitation appears to be related to clinical practice in NICUs, where the majority of patients did not receive pain assessment with a scale, as was reported in a study of 30 NICUs where 16.7% of the neonates received a pain assessment with a scale [48] , while painful procedures such as tracheal intubation and cardiac surgery were assessed with pain scales in 58 and 56.7% of the neonates, respectively [41,49] . Another limitation was that DHA-containing oil had higher saturated fatty acids: lauric, myristic and palmitic, but lower linoleic and oleic acids compared with SO administered to the control group.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, it was reported that 74% of neonates from 243 European NICUs received opioids during NICU stay, and the use of opioids were associated with prolonged duration of tracheal intubation, regardless whether they underwent a surgery [41] . Our result from the control group is consistent with above-mentioned study, but the DHA group remained at similar cumulative dose of buprenorphine ( fig.…”

Section: Discussionmentioning

confidence: 99%

Enteral Docosahexaenoic Acid Reduces Analgesic Administration in Neonates Undergoing Cardiovascular Surgery

et al. 2016

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Background: Neonates undergoing surgery require analgesic medication to ameliorate acute pain. These medications produce negative side effects. Docosahexaenoic acid (DHA) has an antinociceptive effect in animals, but this has not been evaluated in human neonates. We evaluated the DHA effect on cumulative dose and duration of analgesics administered to neonates undergoing cardiovascular surgery. Methods: A secondary analysis was performed with data from a clinical trial, in which enteral DHA was administered perioperatively compared with sunflower oil (SO). Present study assessed the antinociceptive effect of DHA by measuring the cumulative dose and duration of analgesics administered during postoperative stay in a neonatal intensive care unit. Multivariate linear regression models were performed. Results: Seventeen neonates received DHA and 18 received SO in the control group. Compared with the control group, the DHA group received lower cumulative dose (14.6 ± 2.2 vs. 25.2 ± 4.8 μg/kg, p = 0.029) and shorter duration of buprenorphine (2 days (1-8) vs. 4.5 days (1-12); p = 0.053). After adjusting for confounders, the DHA group received significantly lesser buprenorphine (β = -27 μg/kg, p = 0.028; R² model = 0.90) for shorter duration (β = -9 days, p = 0.003; R² model = 0.94). No differences in fentanyl or ketorolac were detected. Conclusions: Buprenorphine administration was reduced in neonates who received DHA, suggesting that DHA likely has analgesic effects.

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“…Each unit also kept a logbook of all neonates admitted during the study period. A centralized team in Paris monitored the completeness and relevance of the data entered in the study database, as reported in an earlier publication [21]. After obtaining the approval of the regulatory bodies for the Protection of Human Subjects, Data Protection, and Health Research Data Management in France, the study was also approved by the local ethical committees of the participating hospitals.…”

Section: Methodsmentioning

confidence: 99%

“…The EUROPAIN survey is the first study, to our knowledge, to have prospectively recorded round-the-clock bedside A/S and PA practices for all NICU admissions over a defined period of time, generating a precise picture of these practices [21]. …”

Section: Introductionmentioning

confidence: 99%

Sedation and analgesia practices at Italian neonatal intensive care units: results from the EUROPAIN study

et al. 2017

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BackgroundWe aimed to examine current bedside analgesia/sedation (A/S) and pain assessment (PA) practices in Italian neonatal intensive care units (NICUs) in relation to the findings of an epidemiological European study and recently-introduced national guidelines.MethodsWe analyzed the Italian data from the EUROPAIN (EUROpean-Pain-Audit-In-Neonates) prospective observational study on A/S practices that involved 6680 newborns admitted to tertiary-level NICUs in 18 European countries. Demographics, type of assisted ventilation, type and mode of A/S administration and PA were analyzed. Multivariate linear regression models were used to identify factors predicting A/S and PA practices.ResultsFrom October 1st, 2012 to June 30th, 2013, thirty Italian NICUs gathered data on 422 newborn: 131 on invasive ventilation (IV); 150 on noninvasive ventilation (NIV); and 141 on spontaneous ventilation (SV). A/S was documented for 35.3% of all infants admitted (86.3% IV; 17.3% NIV; 7.1% SV [p = 0.0001]), and varied considerably between NICUs (as reported in other European countries). Strong analgesics were used in 32.5% of cases, sedatives in 10.2%, mild analgesics in 3.8%. Fentanyl was used in 78.6% of cases, morphine in 8.4%, neuromuscular blockers in 5.3%, midazolam in 22.1%. The performance of PA was documented in 67.5% of all newborn (85.5% IV; 67.3% NIV; 51.1% SV [p = 0.001]). Illness severity, type of ventilation, bedside PA, and number of NICU beds were all factors associated with A/S use on multivariate analysis, while gestational age ≤ 32 weeks, and type of ventilation and presence of a pain team were associated with PA.ConclusionsWe documented a generally widespread, but still highly variable use of A/S and PA at Italian NICUs, despite the diffusion of national guidelines. There is an urgent need to improve routine PA to enable customized pain and stress control (and prevention) in all infants.Trial registrationClinical Trials.gov # NCT01694745.Electronic supplementary materialThe online version of this article (doi:10.1186/s13052-017-0343-2) contains supplementary material, which is available to authorized users.

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Sedation and analgesia practices in neonatal intensive care units (EUROPAIN): results from a prospective cohort study

Abstract: SummaryBackground Neonates who are in pain or are stressed during care in the intensive care unit (ICU) are often given sedation or analgesia. We investigated the current use of sedation or analgesia in neonatal ICUs (NICUs) in European countries.

Cited by 160 publications

References 54 publications

Dexmedetomidine, agitated delirium, and “off-label” drugs

Dexmedetomidine, agitated delirium, and “off-label” drugs

Enteral Docosahexaenoic Acid Reduces Analgesic Administration in Neonates Undergoing Cardiovascular Surgery

Sedation and analgesia practices at Italian neonatal intensive care units: results from the EUROPAIN study

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