Music Interventions in Pediatric Surgery (The Music Under Surgery In Children Study): A Randomized Clinical Trial.

BACKGROUND: Perioperative music interventions have been shown to reduce anxiety and pain in adults. This inexpensive, easily applicable intervention could be of benefit to children as well. Our objective was to determine the effects of music interventions on distress, anxiety, and postoperative pain in infants undergoing surgery. METHODS: The Music Under Surgery In Children study was designed as a parallel, single-blind, randomized controlled trial with an a priori formulated hypothesis. Data were collected between August 2015 and October 2016 in a single tertiary care children's hospital. There was a 24-hour follow-up with blind primary outcome assessment. A random sample of 432 eligible 0-3 years of age infants admitted for orchidopexy, hypospadias, or inguinal hernia repair receiving general anesthesia and caudal block were asked for participation. Subjects were assigned to a preoperative music intervention, pre- and intraoperative music intervention, or no music intervention (control) via random allocation using a computer-generated list with the use of opaque envelopes. The main outcome measure was the postoperative level of distress assessed with the COMFORT-Behavior scale, which is an observational scale; furthermore, preoperative level of distress, preoperative anxiety, and physiological measurements such as heart rate (HR) and blood pressure were measured. The trial was registered at the Dutch Trial Register, number NTR5402 (www.trialregister.nl). RESULTS: One hundred ninety-five infants with median age 6.9 months (interquartile range, 3.3-11.1) were randomized, 178 of whom were included in the primary analysis. A nonsignificant difference in COMFORT-Behavior scale scores between the pre- and intraoperative music intervention group and control group at 4 hours after surgery was found (mean difference, -1.22; 95% CI, 2.60-0.17; P = .085). Additional analysis showed weak nonsignificant evidence for an interaction effect between music exposure and COMFORT-Behavior score at baseline (P = .027 with a Bonferroni-adjusted significance level of .025). General linear modeling showed a statistically significantly reduced HR after the preoperative music intervention in the holding area in the combined preoperative music intervention and intraoperative music intervention group compared to the control group (P = .003). The differences in HR among the 3 study arms at all time points were not statistically significant (P = .069). CONCLUSIONS: Music interventions do not seem to benefit all young infants undergoing surgery. The potential benefits of music interventions in the preoperative period and in more distressed children warrant further exploration.

Prevalence and risk factors of iron deficiency in healthy young children in the southwestern Netherlands.

OBJECTIVES: Iron deficiency (ID) and iron deficiency anemia (IDA), during the first years of life, are associated with delayed motor and neurological development. Many studies evaluated iron status without an assessment of an acute-phase protein to identify infection. Because most indicators of iron status are influenced by infection, these data may underestimate the ID prevalence. A food consumption survey in the Netherlands showed that the mean iron intake of children ages 2 to 3 years was below the advised adequate intake of 7 mg/day. The aim of the study was to investigate iron status in a well-defined, healthy population of young children in the southwestern region of the Netherlands and to identify risk factors for ID. METHODS: We conducted a multicenter, observational study in healthy children ages 0.5 to 3 years. We defined ID as ferritin <12 µg/L and IDA when, in addition, hemoglobin was <110 g/L. Children with elevated C-reactive protein levels (>5 mg/L) or underlying causes for anemia were excluded. Parents filled in a questionnaire to identify risk factors for ID. RESULTS: We included 400 children in the study. ID and IDA were detected in 18.8% and 8.5% of the children, respectively. The present use of formula and the visit of preschool/day care were associated with a lower prevalence of ID, and a high intake of cow's milk was associated with a higher prevalence of ID, after adjustment for age. CONCLUSIONS: ID is present in 18.8% of healthy children ages 0.5 to 3 years and living in the southwestern region of the Netherlands. The present visit of preschool/day care and the use of formula are associated with a reduced risk of ID, whereas a high intake of cow's milk is associated with an increased risk of ID.

Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: a randomized controlled trial.

IMPORTANCE: Continuous morphine infusion as standard postoperative analgesic therapy in young infants is associated with unwanted adverse effects such as respiratory depression. OBJECTIVE: To determine whether intravenous paracetamol (acetaminophen) would significantly (>30%) reduce morphine requirements in neonates and infants after major surgery. DESIGN, SETTING, AND PATIENTS: Single-center, randomized, double-blind study conducted in a level 3 pediatric intensive care unit in Rotterdam, The Netherlands. Patients were 71 neonates or infants younger than 1 year undergoing major thoracic (noncardiac) or abdominal surgery between March 2008 and July 2010, with follow-up of 48 hours. INTERVENTIONS: All patients received a loading dose of morphine 30 minutes before the end of surgery, followed by continuous morphine or intermittent intravenous paracetamol up to 48 hours postsurgery. Infants in both study groups received morphine (boluses and/or continuous infusion) as rescue medication on the guidance of the validated pain assessment instruments. MAIN OUTCOME MEASURES: Primary outcome was cumulative morphine dose (study and rescue dose). Secondary outcomes were pain scores and morphine-related adverse effects. RESULTS: The cumulative median morphine dose in the first 48 hours postoperatively was 121 (interquartile range, 99-264) µg/kg in the paracetamol group (n = 33) and 357 (interquartile range, 220-605) µg/kg in the morphine group (n = 38), P < .001, with a between-group difference that was 66% (95% CI, 34%-109%) lower in the paracetamol group. Pain scores and adverse effects were not significantly different between groups. CONCLUSION AND RELEVANCE: Among infants undergoing major surgery, postoperative use of intermittent intravenous paracetamol compared with continuous morphine resulted in a lower cumulative morphine dose over 48 hours. TRIAL REGISTRATION: trialregister.nl Identifier: NTR1438.

Pain management in intellectually disabled children: a survey of perceptions and current practices among Dutch anesthesiologists.

BACKGROUND: Intellectually disabled children are more likely to undergo surgical interventions and almost all have comorbidities that need to be managed. Compared with controls, intellectually disabled children tend to receive less intraoperative analgesia and fewer of them are assessed for postoperative pain. AIM: To evaluate perceptions and practices of anesthesiologists in the Netherlands concerning pain management in intellectually disabled children. METHODS/MATERIALS: We surveyed members of the Section on Pediatric Anesthesiology of the Netherlands Society of Anesthesiology in 2005 and 2009, using a self-designed questionnaire. RESULTS: The response rate was 47% in both years. In 2005, 32% of the anesthesiologists rated intellectually disabled children as 'more sensitive to pain' than nonintellectually disabled children--vs 25% in 2009. But no more than 7% in 2005 vs 6% in 2009 agreed with the statement 'children with intellectually disabled children need more analgesia'. Most anesthesiologists gave similar doses of intraoperative opioids for intellectually disabled and nonintellectually disabled children, 92% in 2005 vs 89% in 2009. In 2005, only 3% applied a pain assessment tool validated for intellectually disabled children, vs 4% in 2009. CONCLUSIONS: Anesthesiologists in the Netherlands take a different approach when caring for intellectually disabled children and they were not aware of pain observation scales for these children. However, the majority think that intellectually disabled children are not more sensitive to pain or require more analgesia. These opinions did not change over the 4-year period. One way to proceed is to implement validated pain assessment tools and to invest in education.

Lower bispectral index values in children who are intellectually disabled.

BACKGROUND: Very few data are available on the use of bispectral index (BIS) monitoring in children who are intellectually disabled. Epileptiform electroencephalogram activity, underlying cerebral pathology, or anticonvulsant/spasmolytic therapy might influence BIS monitoring. Our aim in this exploratory study was to first compare BIS values at 4 different stages of anesthesia between intellectually disabled children and controls. Our second aim was to investigate the discriminative properties of BIS between consciousness and unconsciousness for intellectually disabled children and for controls. METHODS: Eighteen intellectually disabled children and 35 control children, aged 2-13 yr, were included. BIS values, landmark events, and standard monitoring values of vital functions were recorded throughout the whole procedure. The performance of BIS in distinguishing between a conscious and unconscious state was assessed from receiver operating characteristic curves. RESULTS: Median (interquartile range) BIS values for the intellectually disabled group were significantly lower than those for controls in the awake state (72 [48-77] vs 97 [84-98], P < 0.001), during stable intraoperative anesthesia (34 [21-45] vs 43 [33-52], P = 0.02), and during return of consciousness (59 [36-68] vs 73 [64-78], P = 0.009). The discriminative properties of the BIS monitor for the state of consciousness were comparable between the 2 groups according to the receiver operating characteristic curves. Nevertheless, the optimal cutoff BIS value for discrimination between conscious and unconscious state was 28 points lower for the intellectually disabled group. CONCLUSIONS: We advise anesthesiologists to be alert to possible lower BIS values in intellectually disabled children. There is a risk that they will inadvertently misinterpret the state of consciousness in intellectually disabled children. New multicenter studies must find the optimal manner of evaluating (un)consciousness in intellectually disabled patients with documented and confirmed specific etiologies of their intellectual disability.

Comparison of bispectral index and composite auditory evoked potential index for monitoring depth of hypnosis in children.

BACKGROUND: In pediatric patients, the Bispectral Index (BIS), derived from the electroencephalogram, and the composite A-Line autoregressive index (cAAI), derived from auditory evoked potentials and the electroencephalogram, have been used as measurements of depth of hypnosis during anesthesia. The performance and reliability of BIS and cAAI in distinguishing different hypnotic states in children, as evaluated with the University of Michigan Sedation Scale, were compared. METHODS: Thirty-nine children (aged 2-16 yr) scheduled to undergo elective inguinal hernia surgery were studied. For all patients, standardized anesthesia was used. Prediction probabilities of BIS and cAAI versus the University of Michigan Sedation Scale and sensitivity/specificity were calculated. RESULTS: Prediction probabilities for BIS and cAAI during induction were 0.84 for both and during emergence were 0.75 and 0.74, respectively. At loss of consciousness, the median BIS remained unaltered (94 to 90; not significant), whereas cAAI values decreased (60 to 43; P < 0.001). During emergence, median BIS and cAAI increased from 51 to 74 (P < 0.003) and from 46 to 58 (P < 0.001), respectively. With respect to indicate consciousness or unconsciousness, 100% sensitivity was reached at cutoff values of 17 for BIS and 12 for cAAI. One hundred percent specificity was associated with a BIS of 71 and a cAAI of 60. To ascertain consciousness, BIS values greater than 78 and cAAI values above 52 were required. CONCLUSIONS: BIS and cAAI were comparable indicators of depth of hypnosis in children. Both indices, however, showed considerable overlap for different clinical conditions.

A comparison in adolescents of composite auditory evoked potential index and bispectral index during propofol-remifentanil anesthesia for scoliosis surgery with intraoperative wake-up test.

BACKGROUND: The electroencephalogram-derived Bispectral Index (BIS), and the composite A-line ARX index (cAAI), derived from the electroencephalogram and auditory evoked potentials, have been promoted as anesthesia depth monitors. Using an intraoperative wake-up test, we compared the performance of both indices in distinguishing different hypnotic states, as evaluated by the University of Michigan Sedation Scale, in children and adolescents during propofol-remifentanil anesthesia for scoliosis surgery. Postoperative explicit recall was also evaluated. METHODS: Twenty patients (aged 10-20 yr) were enrolled. Prediction probabilities were calculated for induction, wake-up test, and emergence. BIS and cAAI were compared at the start of the wake-up test, at purposeful movement to command, and after the patient was reanesthetized. During the wake-up test, patients were instructed to remember a color, and were then interviewed for explicit recall. RESULTS: Prediction probabilities of BIS and cAAI for induction were 0.82 and 0.63 (P < 0.001), for the wake-up test, 0.78 and 0.79 (P < 0.001), and 0.74 and 0.78 for emergence (P < 0.001). During the wake-up test, a significant increase in mean BIS and cAAI (P < 0.05) was demonstrated at purposeful movement, followed by a significant decline after reintroduction of anesthesia. CONCLUSIONS: During induction, BIS performed better than cAAI. Although cAAI was statistically a better discriminator for the level of consciousness during the wake-up test and emergence, these differences do not appear to be clinically meaningful. Both indices increased during the wake-up test, indicating a higher level of consciousness. No explicit recall was demonstrated.

Pain in Intellectually Disabled Children: Towards Evidence-Based Pharmacotherapy?

This critical opinion article deals with the challenges of finding the most effective pharmacotherapeutic options for the management of pain in intellectually disabled children and provides recommendations for clinical practice and research. Intellectual disability can be caused by a wide variety of underlying diseases and may be associated with congenital anomalies such as cardiac defects, small-bowel obstructions or limb abnormalities as well as with comorbidities such as scoliosis, gastro-esophageal reflux disease, spasticity, and epilepsy. These conditions themselves or any necessary surgical interventions are sources of pain. Epilepsy often requires chronic pharmacological treatment with antiepileptic drugs. These antiepileptic drugs can potentially cause drug-drug interactions with analgesic drugs. It is unfortunate that children with intellectual disabilities often cannot communicate pain to caregivers. Although these children are at high risk of experiencing pain, researchers nevertheless often have to exclude them from trials on pain management because of ethical considerations. We therefore make a plea for prescribers, researchers, patient organizations, pharmaceutical companies, and policy makers to study evidence-based, safe and effective pharmacotherapy in these children through properly designed studies. In the meantime, parents and clinicians must resort to validated pain assessment tools such as the revised FLACC scale.