Background This position statement provides clinical recommendations for the assessment of pain, level of sedation, iatrogenic withdrawal syndrome and delirium in critically ill infants and children. Admission to a neonatal or paediatric intensive care unit (NICU, PICU) exposes a child to a series of painful and stressful events. Accurate assessment of the presence of pain and non-pain-related distress (adequacy of sedation, iatrogenic withdrawal syndrome and delirium) is essential to good clinical management and to monitoring the effectiveness of interventions to relieve or prevent pain and distress in the individual patient. Methods A multidisciplinary group of experts was recruited from the members of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). The group formulated clinical questions regarding assessment of pain and non-pain-related distress in critically ill and nonverbal children, and searched the PubMed/Medline, CINAHL and Embase databases for studies describing the psychometric properties of assessment instruments. Furthermore, level of evidence of selected studies was assigned and recommendations were formulated, and grade or recommendations were added on the basis of the level of evidence. Results An ESPNIC position statement was drafted which provides clinical recommendations on assessment of pain (n = 5), distress and/or level of sedation (n = 4), iatrogenic withdrawal syndrome (n = 3) and delirium (n = 3). These recommendations were based on the available evidence and consensus amongst the experts and other members of ESPNIC. Conclusions This multidisciplinary ESPNIC position statement guides professionals in the assessment and reassessment of the effectiveness of treatment interventions for pain, distress, inadequate sedation, withdrawal syndrome and delirium.

Background This study aimed to evaluate anxiety and pain following perioperative music interventions compared with control conditions in adult patients. Methods Eleven electronic databases were searched for full‐text publications of RCTs investigating the effect of music interventions on anxiety and pain during invasive surgery published between 1 January 1980 and 20 October 2016. Results and data were double‐screened and extracted independently. Random‐effects meta‐analysis was used to calculate effect sizes as standardized mean differences (MDs). Heterogeneity was investigated in subgroup analyses and metaregression analyses. The review was registered in the PROSPERO database as CRD42016024921. Results Ninety‐two RCTs (7385 patients) were included in the systematic review, of which 81 were included in the meta‐analysis. Music interventions significantly decreased anxiety (MD –0·69, 95 per cent c.i. –0·88 to –0·50; P < 0·001) and pain (MD –0·50, –0·66 to –0·34; P < 0·001) compared with controls, equivalent to a decrease of 21 mm for anxiety and 10 mm for pain on a 100‐mm visual analogue scale. Changes in outcome corrected for baseline were even larger: MD –1·41 (–1·89 to –0·94; P < 0·001) for anxiety and –0·54 (–0·93 to –0·15; P = 0·006) for pain. Music interventions provided during general anaesthesia significantly decreased pain compared with that in controls (MD –0·41, –0·64 to –0·18; P < 0·001). Metaregression analysis found no significant association between the effect of music interventions and age, sex, choice and timing of music, and type of anaesthesia. Risk of bias in the studies was moderate to high. Conclusion Music interventions significantly reduce anxiety and pain in adult surgical patients.

The aim of this study was to test the reliability and validity of the COMFORT scale as a postoperative pain instrument for children aged 0-3 years. Subjects were 158 neonates and toddlers after major abdominal or thoracic surgery. Trained nurses rated the children's pain at 3, 6 and 9 h postoperative on the Pediatric Surgical Intensive Care Unit using the COMFORT and a VAS for pain. Interrater reliability of the COMFORT items proved to be good (Kappa 0.63-0.93) for all items with the exception of the item 'Respiratory response', which was moderate (Kappa 0.54). LISREL analyses showed that the structure of the COMFORT data was best represented by three latent variables: COMFORT 'behaviour' with loadings from the behavioural items (Alertness, Calmness, Respiratory response/Crying, Physical movement, Muscle tone and Facial tension) and separate latent variables for 'Heart rate baseline' (HR) and 'Mean arterial blood pressure baseline' (MAP). Factor loadings of the items were invariant across time, indicating stability of the structure. The latent variables COMFORT 'behaviour' and VAS pain were highly interrelated indicating congruent validity. Stability of COMFORT 'behaviour' and VAS pain was moderate which might be due to varying painful episodes in this sample. HR and MAP, although stable across time, were weakly related to VAS pain and COMFORT 'behaviour'. These findings support the use of the COMFORT 'behaviour' scale to assess postoperative pain in neonates and infants.

The original COMFORT scale, including both observational and physiologic items, has been validated for measuring distress in children admitted to a pediatric intensive care unit. However, physiologic variables are influenced by drugs given in the pediatric intensive care unit setting. The objectives of this study were to assess the usefulness of physiologic variables in judgment of sedation and to determine new cutoff points for the COMFORT “behavioral” scale (COMFORT-B), using only observational items. Prospective observational study. Pediatric intensive care unit in a university hospital Seventy-eight patients admitted to the pediatric intensive care unit. None. COMFORT scores were obtained in this patient group. Similar to the original COMFORT scale validation, the expert opinion of nurses (Nurse Interpretation Score of Sedation) served to determine optimal cutoff scores for the COMFORT-B scale. A total of 843 combined COMFORT and Nurse Interpretation Score of Sedation scores were obtained in 78 patients. Cronbach’s alpha for the COMFORT scale was .78, increasing to .84 when the physiologic items, blood pressure and heart rate, were excluded. COMFORT scores were significantly different for the three Nurse Interpretation Score of Sedation categories (Kruskal-Wallis, p < .001). According to the pediatric intensive care unit nurses, undersedation was present in 11% and oversedation in 3% of all observations. Cutoff points for the COMFORT-B scale were ≤10 for oversedation and ≥23 for undersedation. The area in the COMFORT-B score between 11 and 22 does not adequately predict under- or oversedation, pointing to a need for supplemental observation. The COMFORT-B scale is a reliable alternative to the original COMFORT scale. The cutoff points of the COMFORT-B scale in conjunction with the Nurse Interpretation Score of Sedation facilitate the use of sedation algorithms on the pediatric intensive care unit.

Pain assessment is essential to tailor intensive care of neonates. The present focus is on acute procedural pain; assessment of pain of longer duration remains a challenge. We therefore tested a modified version of the COMFORT-behavior scale—named COMFORTneo—for its psychometric qualities in the Neonatal Intensive Care Unit setting. In a clinical observational study, nurses assessed patients with COMFORTneo and Numeric Rating Scales (NRS) for pain and distress, respectively. Interrater reliability, concurrent validity, and sensitivity to change were calculated as well as sensitivity and specificity for different cut-off scores for subsets of patients. Interrater reliability was good: median linearly weighted Cohen κ 0.79. Almost 3600 triple ratings were obtained for 286 neonates. Internal consistency was good (Cronbach α 0.84 and 0.88). Concurrent validity was demonstrated by adequate and good correlations, respectively, with NRS-pain and NRS-distress: r=0.52 (95% confidence interval 0.44-0.59) and r=0.70 (95% confidence interval 0.64-0.75). COMFORTneo cut-off scores of 14 or higher (score range is 6 to 30) had good sensitivity and specificity (0.81 and 0.90, respectively) using NRS-pain or NRS-distress scores of 4 or higher as criterion. The COMFORTneo showed preliminary reliability. No major differences were found in cut-off values for low birth weight, small for gestational age, neurologic impairment risk levels, or sex. Multicenter studies should focus on establishing concurrent validity with other instruments in a patient group with a high probability of ongoing pain.

Does pain or tissue damage in early life lead to hyperalgesia persisting into childhood? We performed a cross-sectional study in 164 infants to investigate whether major surgery within the first 3 months of life increases pain sensitivity to subsequent surgery and to elucidate whether subsequent surgery in the same dermatome or in a different dermatome leads to differences in pain sensitivity. All infants received standard intraoperative and postoperative pain management, with rescue analgesia guided by a treatment algorithm. Differences in pain sensitivity during surgery were assessed by the intraoperative fentanyl intake and by (nor)epinephrine plasma concentrations. Differences in postoperative pain sensitivity were assessed by the observational pain measures COMFORT and VAS, and by morphine intake and (nor)epinephrine plasma concentrations. Infants previously operated upon in the same dermatome needed more intraoperative fentanyl, had higher COMFORT and VAS scores, had greater (nor)epinephrine plasma concentrations, and needed also more morphine than did infants with no prior surgery. In contrast, infants who previously underwent surgery in another dermatome had only significant higher postoperative analgesic requirements and norepinephrine plasma concentrations in comparison with infants with no prior surgery. These preliminary differences may indicate the occurrence of spinal and supraspinal changes following neonatal surgery. We conclude that the long-term consequences of surgery in early infancy are greater in areas of prior tissue damage and that these effects may portend limited clinical but important neurobiological differences.