Music Therapy During Basic Daily Care in Critically Ill Children: A Randomized Crossover Clinical Trial.

OBJECTIVE: To assess whether music therapy (MT) is effective to reduce pain during daily personal hygiene care (DPHC), a procedure performed in all patients in a pediatric intensive care unit. METHODS: Fifty critically ill children were enrolled in a crossover controlled clinical trial with random ordering of the intervention, that is, passive MT, and standard conditions, and blind assessment of pain on film recordings. The primary outcome was variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during DPHC. Secondary outcomes were changes in heart rate, respiratory rate, and mean arterial blood pressure, and administration of analgesic or sedative drugs during DPHC. Mixed-effects linear model analysis was used to assess effect size (95% CI). RESULTS: The median (Q25-Q75) age and weight of the patients were 3.5 years (1.0-7.6 years) and 15.0 kg (10.0-26.8 kg). Consecutive DPHC were assessed on days 3 (2-5) and 4 (3-7) of hospitalization. In standard conditions, FLACC score was 0.0 (0.0-3.0) at baseline and 3.0 (1.0-5.5) during DPHC. With MT, these values were, respectively, 0.0 (0.0-1.0) and 2.0 (0.5-4.0). Rates of FLACC scores of >4 during DPHC, which indicates severe pain, were 42% in standard conditions and 17% with MT (P = .013). Mixed-effects model analysis found smaller increases in FLACC scores (-0.54 [-1.08 to -0.01]; P = .04) and heart rate (-9.00; [-14.53; -3.40]; P = .001) with MT. CONCLUSIONS: MT is effective to improve analgesia in critically ill children exposed to DPHC. TRIAL REGISTRATION: This study was recorded (April 16, 2019) before patient recruitment on the National Library of Medicine registry (NCT03916835; https://clinicaltrials.gov/ct2/show/NCT03916835).

Hypnosis as an alternative to general anaesthesia for paediatric superficial surgery: a randomised controlled trial.

BACKGROUND: Reducing perioperative anxiety and controlling pain in children are essential to optimise recovery and outcomes for both children and their parents. By acting on sensory and affective modulation of anxiety and pain, hypnosis is widely used in medical care, especially in anaesthesia. This randomised controlled clinical trial was designed to compare general anaesthesia and intraoperative hypnosis support for perioperative management of children undergoing superficial surgery. METHODS: Children aged 7-16 yr scheduled for day-case superficial surgery were included and randomly assigned to one of the following two groups: general anaesthesia group or hypnosis group. The primary outcome was length of hospital stay. Child and parent anxiety, child pain, and the occurrence of postoperative negative behavioural changes were also evaluated. RESULTS: Sixty children of mean age 10.3 (standard deviation: 2.6) yr were enrolled in the study. Hypnosis was successful in all but one case. The median (25th-75th percentile) length of hospital stay was shorter in the hypnosis group (120 [95-145] vs 240.5 [218-275] min; P<0.001). The general anaesthesia group was associated with a greater incidence of high levels of preoperative anxiety in children (30 vs 11%; P=0.001) and parents (55 vs 30%; P=0.05). Pain scores did not differ between groups. No negative postoperative behavioural changes were reported. CONCLUSIONS: In children aged 7-16 yr, hypnosis appears to be feasible and accepted. The quality of the perioperative experience and the rapid recovery support the use of hypnosis as an effective and safe alternative to general anaesthesia for paediatric superficial surgery. CLINICAL TRIAL REGISTRATION: NCT02505880.

Epidemiology of regional anesthesia in children: Lessons learned from the European Multi-Institutional Study APRICOT.

BACKGROUND: Recently, the European prospective observational multicenter cohort study, APRICOT, reported anesthesia techniques and complications in more than 31 000 pediatric procedures. The main objective of this study was to analyze the current practice in regional anesthesia in the 33 countries that participated to APRICOT. METHODS: Data on regional anesthesia techniques were extracted from the database of APRICOT (261 centers across 33 European countries). All children, aged from birth to 16 years old, were eligible for inclusion during a 2-week period. Type of regional anesthesia, whether used awake or with sedation or general anesthesia, techniques of guidance, and the drugs administered were analyzed. RESULTS: Regional anesthesia was used in 4377 pediatric surgical procedures. The large majority was performed under general anesthesia with central blocks and truncal blocks, representing, respectively, 42.6% and 41.8% of performed techniques. Caudal blocks represented 76.9% of all central blocks. The penile and ilioinguinal/iliohypogastric blocks were the most commonly performed truncal blocks. Anesthetists used mainly anatomical landmarks; ultrasound guidance was applied in only 23.8% of cases. A wide variability of practices was observed in terms of regional anesthesia techniques and local anesthetics among the participating European countries. No serious complications were reported. CONCLUSION: These data show a large predominance of central and truncal blocks in APRICOT study. Ultrasound guidance was mainly used for peripheral nerve blocks while central blocks were performed using landmark techniques.

Transversus Abdominal Plane Block in Children: Efficacy and Safety: A Randomized Clinical Study and Pharmacokinetic Profile.

BACKGROUND: The transversus abdominis plane (TAP) block has become a common regional anesthesia technique for pain management in a wide variety of abdominal procedures. Evidence to support any particular local anesthetic regimen as well as pharmacokinetic and systemic toxicity risks of TAP block remain insufficiently studied in children. The aim of this study was to compare the analgesic effects and investigate pharmacokinetic profile of levobupivacaine after ultrasound-guided TAP block using a low volume/high concentration (LVHC) or a high volume/low concentration (HVLC) solution in children. METHODS: This prospective randomized study included children scheduled for day-case inguinal surgery. Children were randomized to receive TAP block using 0.4 mg·kg levobupivacaine as either HVLC (0.2 mL·kg of 0.2% levobupivacaine) or LVHC (0.1 mL·kg of 0.4% levobupivacaine). The primary outcome was the number of children who required opioid rescue analgesia postoperatively. Pharmacokinetic profile study of levobupivacaine was also performed. RESULTS: Seventy patients were equally randomized, and 65 were included in the final analysis. Seventy-one percent of patients did not require any postoperative opioid analgesia. The number of patients who received rescue analgesia was 12 (35%) in the LVHC group and 7 (23%) in the HVLC group (relative risk, 0.64; 95% confidence interval [CI], 0.29-1.42; P = .26). Mean pain scores (FLACC [faces, legs, activity, cry, and consolability]) at postanesthesia care unit discharge did not differ between LVHC and HVLC groups, respectively, 0.39 ± 0.86 and 1 ± 1.71 with mean group difference -0.60 (95% CI, -1.27 to 0.06; P = .08). The pharmacokinetic profile of levobupivacaine was comparable in the 2 groups: the mean total and free levobupivacaine peak concentrations were 379 ± 248 and 3.95 ± 3.16 ng·mL, respectively, occurring 22.5 ± 11 minutes after injection. The highest total and free levobupivacaine concentrations collected, respectively, 1360 and 15.1 ng·mL, remained far below theoretical toxic thresholds. CONCLUSIONS: In children, quality of postoperative pain control provided by TAP block using levobupivacaine 0.4 mg·kg administered as either HVLC or LVHC did not differ and was associated with a very low risk of local anesthetic systemic toxicity.

Preoperative Epoetin-α with Intravenous or Oral Iron for Major Orthopedic Surgery: A Randomized Controlled Trial.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Preoperative administration of epoetin-α with iron is commonly used in anemic patients undergoing major orthopedic surgery, but the optimal route of iron intake is controversial. The aim of this study was to compare the clinical effects of erythropoietin in combination with oral or intravenous iron supplementation. METHODS: This study was a prospective, randomized, single-blinded, parallel arm trial. Patients scheduled for elective hip or knee arthroplasty with hemoglobin 10 to 13 g/dl received preoperative injections of erythropoietin with oral ferrous sulfate or intravenous ferric carboxymaltose. The primary endpoint was the hemoglobin value the day before surgery. RESULTS: One hundred patients were included in the analysis. The day before surgery, hemoglobin, increase in hemoglobin, and serum ferritin level were higher in the intravenous group. For the intravenous and oral groups, respectively, hemoglobin was as follows: median, 14.9 g/dl (interquartile range, 14.1 to 15.6) versus 13.9 g/dl (interquartile range, 13.2 to 15.1), group difference, 0.65 g/dl (95% CI, 0.1 to 1.2; P = 0.017); increase in hemoglobin: 2.6 g/dl (interquartile range, 2.1 to 3.2) versus 1.9 g/dl (interquartile range, 1.4 to 2.5), group difference, 0.7 g/dl (95% CI, 0.3 to 1.1; P < 0.001); serum ferritin: 325 µg/l (interquartile range, 217 to 476) versus 64.5 µg/l (interquartile range, 44 to 107), group difference, 257 µg/l (95% CI, 199 to 315; P < 0.001). The percentage of patients with nausea, diarrhea, or constipation was higher in the oral group, 52% versus 2%; group difference, 50% (95% CI, 35 to 64%; P < 0.0001). CONCLUSIONS: After preoperative administration of erythropoietin, body iron stores and stimulation of the erythropoiesis were greater with intravenous ferric carboxymaltose than with oral ferrous sulfate supplementation.

Estimation and pharmacodynamic consequences of the minimum effective anesthetic volumes for median and ulnar nerve blocks: a randomized, double-blind, controlled comparison between ultrasound and nerve stimulation guidance.

BACKGROUND: Nerve stimulation and ultrasound guidance are the most popular techniques for peripheral nerve blocks. However, the minimum effective anesthetic volume (MEAV) in selected nerves for both techniques and the consequences of decreasing the local anesthetic volume on the pharmacodynamic characteristics of nerve block remain unstudied. We designed a randomized, double-blind controlled comparison between neurostimulation and ultrasound guidance to estimate the MEAV of 1.5% mepivacaine and pharmacodynamics in median and ulnar nerve blocks. METHODS: Patients scheduled for carpal tunnel release were randomized to ultrasound guidance (UG) or neurostimulation (NS) groups. A step-up/step-down study model (Dixon method) was used to determine the MEAV with nonprobability sequential dosing based on the outcome of the previous patient. The starting dose of 1.5% mepivacaine was 13 and 11 mL for median and ulnar nerves at the humeral canal. Block success/failure resulted in a decrease/increase of 2 mL. A blinded physician assessed sensory blockade at 2-minute intervals for 20 minutes. Block onset time and duration were noted. RESULTS: The MEAV50 (SD) of the median nerve was lower in the UG group 2 (0.1) mL (95% confidence interval [CI] = [1, 96] to [2, 04]) than in the NS group 4 (3.8) mL (95% CI = [2, 4] to [5, 6]) (P = 0.017). There was no difference for the ulnar nerve between UG group 2 (0.1) mL (95% CI = [1, 96] to [2, 04]) and NS group 2.4 (0.6) mL (95% CI = [2, 1] to [2, 7]). The duration of sensory blockade was significantly correlated to local anesthetic volume, but onset time was not modified. CONCLUSION: Ultrasound guidance selectively provided a 50% reduction in the MEAV of mepivacaine 1.5% for median nerve sensory blockade in comparison with neurostimulation. Decreasing the local anesthetic volume can decrease sensory block duration but not onset time.