Intravenous MELAtonin for prevention of Postoperative Agitation and Emergence Delirium in children (MELA-PAED): A protocol and statistical analysis plan for a randomized clinical trial.

BACKGROUND: Emergence agitation and delirium in children remain a common clinical challenge in the post-anesthetic care unit. Preoperative oral melatonin has been suggested as an effective preventive drug with a favorable safety profile. The oral bioavailability of melatonin, however, is low. Therefore, the MELA-PAED trial aims to investigate the efficacy and safety of intraoperative intravenous melatonin for the prevention of emergence agitation in pediatric surgical patients. METHODS: MELA-PAED is a randomized, double-blind, parallel two-arm, multi-center, superiority trial comparing intravenous melatonin with placebo. Four hundred participants aged 1-6 years will be randomized 1:1 to either the intervention or placebo. The intervention consists of intravenous melatonin 0.15 mg/kg administered approximately 30 min before the end of surgery. Participants will be monitored in the post-anesthetic care unit (PACU), and the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) will be performed on days 1, 7, and 14 after the intervention. Serious Adverse Events (SAE) will be assessed up to 30 days after the intervention. RESULTS: The primary outcome is the incidence of emergence agitation, assessed dichotomously as any Watcha score >2 during the participant's stay in the post-anesthetic care unit. Secondary outcomes are opioid consumption in the post-anesthetic care unit and adverse events. Exploratory outcomes include SAEs, postoperative pain, postoperative nausea and vomiting, and time to awakening, to first oral intake, and to discharge readiness. CONCLUSION: The MELA-PAED trial investigates the efficacy of intravenous intraoperative melatonin for the prevention of emergence agitation in pediatric surgical patients. Results may provide further knowledge concerning the use of melatonin in pediatric perioperative care.

Stress ulcer prophylaxis in critically ill children: Protocol for a systematic review.

BACKGROUND: Stress ulcer prophylaxis is the considered standard of care in many critically ill patients in the intensive care unit (ICU). Whether there is overall benefit or harm of stress ulcer prophylaxis in critically ill children is unknown. Accordingly, we aim to assess patient-important benefits and harms of stress ulcer prophylaxis versus placebo or no treatment in critically ill children in the ICU. METHODS/DESIGN: We will conduct a systematic review of randomized clinical trials with meta-analysis and trial sequential analysis and assess the use of proton pump inhibitors (PPIs) or histamine-2-receptor antagonists (H2RAs) versus placebo or no prophylaxis. We will systematically search the Cochrane Library, MEDLINE, EMBASE, Science Citation Index, BIOSIS, and Epistemonikos for relevant literature. We will follow the recommendations by the Cochrane Collaboration and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The risk of systematic errors (bias) and random errors will be assessed, and the overall quality of evidence will be evaluated according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. DISCUSSION: There is a need for an updated systematic review to summarize the benefits and harms of stress ulcer prophylaxis in critically ill children to inform practice and future research.

Is air transport of stroke patients faster than ground transport? A prospective controlled observational study.

BACKGROUND: Helicopters are widely used for interhospital transfers of stroke patients, but the benefit is sparsely documented. We hypothesised that helicopter transport would reduce system delay to thrombolytic treatment at the regional stroke centre. METHODS: In this prospective controlled observational study, we included patients referred to a stroke centre if their ground transport time exceeded 30 min, or they were transported by a secondarily dispatched, physician-staffed helicopter. The primary endpoint was time from telephone contact to triaging neurologist to arrival in the stroke centre. Secondary endpoints included modified Rankin Scale at 3 months, 30-day and 1-year mortality. RESULTS: A total of 330 patients were included; 265 with ground transport and 65 with helicopter, of which 87 (33%) and 22 (34%), received thrombolysis, respectively (p=0.88). Time from contact to triaging neurologist to arrival in the regional stroke centre was significantly shorter in the ground group (55 (34-85) vs 68 (40-85) min, p<0.01). The distance from scene to stroke centre was shorter in the ground group (67 (42-136) km) than in the helicopter group (83 (46-143) km) (p<0.01). We did not detect significant differences in modified Rankin Scale at 3 months, in 30-day (9.4% vs 0%; p=0.20) nor 1-year (18.8% vs 13.6%; p=0.76) mortality between ground and helicopter transport. CONCLUSIONS: We found significantly shorter time from contact to triaging neurologist to arrival in the regional stroke centre if stroke patients were transported by primarily dispatched ground ambulance compared with a secondarily dispatched helicopter.

Response interval is important for survival until admission after prehospital cardiac arrest.

INTRODUCTION: An increasing distance to the nearest hospital must be expected as a result of centralization of acute care at a small number of hospitals. This may have important consequences in emergency situations, such as prehospital or out-of-hospital cardiac arrest (OHCA) where the aim is to obtain return of spontaneous circulation (ROSC), i.e. successful resuscitation. The aim of this study was to describe the impact of response interval on sustained ROSC, i.e. ROSC at hospital admission, after OHCA with presumed cardiac aetiology. MATERIAL AND METHODS: We included all OHCA calls in which the Copenhagen Mobile Emergency Care Unit (MECU) was involved during the 2002-2008 period. Data were collected prospectively and the primary endpoint was sustained ROSC. RESULTS: Resuscitation was attempted in 2,678 OHCA cases. Among these, cardiac aetiology was presumed in 2,327 cases, and 745 patients (32.0%) achieved sustained ROSC. The mean response interval was significantly shorter for patients who obtained sustained ROSC (370 seconds) than for patients who did not (394 seconds) (p = 0.015). CONCLUSION: A significantly shorter response interval was observed in patients who were successfully resuscitated after out-of-hospital cardiac arrest than in patients who were not successfully resuscitated.

Emergency team calls for critically ill non-trauma patients in the emergency department: an observational study.

BACKGROUND: Handling critically ill patients is a complex task for Emergency Department (ED) personnel. Initial treatment is of major importance and requires adequately experienced ED doctors to initiate and decide for the right medical or surgical treatment. Our aim was, with regard to clinical presentation, management and mortality to describe adult non-trauma patients that upon ED arrival elicited emergency team calls. METHODS: An observational study of adult patients (≥ 18 years) admitted to a regional ED with conditions that elicited acute team activation and additional emergency team consultation calls for non-ED specialist physicians. Emergency team calls were two-tiered with 'orange' and 'red' calls. Additionally, intensive care unit (ICU) admission charts were reviewed to identify the total number of adult non-trauma and non-cardiac arrest patients admitted to the ICU from the ED during the study period. RESULTS: A total of 109 emergency team calls were triggered (79 orange and 30 red), comprising 66 (60.6 %) men and 43 women, with a median age of 64 years. Patients presented with: 4 Airway, 27 Breathing, 41 Circulation, 31 Disability, 2 Exposure and 4 Other problems. Overall, 58/109 (53.2 %) patients were admitted to the ICU, while 20/109 (18.3 %) patients were deemed ineligible for ICU admission. 30-day mortality was 34/109 (31.2 %), and circulatory problems were the most frequent cause of death (61.8 %, p = 0.02). Patients who died were significantly older than those who survived (p = 0.004). Additionally, 115 adult patients were admitted to the ICU directly from the ED without eliciting an emergency team call during the study period. These patients mainly comprised patients who were intoxicated, were unconscious or had respiratory failure. CONCLUSION: The majority of emergency team call patients presented with circulatory, disability and breathing problems. Half of the patients were admitted to the ICU, although a high rate of patients was deemed ineligible for ICU admission. 30-day mortality was considerable and circulatory related illnesses were associated with increased short-term mortality.

In-hospital mortality pattern of severely injured children.

BACKGROUND: Although trauma remains a major cause of morbidity and mortality in children, less attention has been directed to this group of patients. Whilst there is considerable literature on trauma in adults, only few studies describe paediatric trauma. The aim of this study was to describe the mortality pattern of severely injured children admitted to a Danish level I trauma centre. METHODS: We included trauma patients aged 15 years or less, who subsequent a trauma team activation were admitted during the 9-year period 1999-2007. Data were collected prospectively for subjects who had a length of stay ≥ 72 h, were admitted to the intensive care unit (regardless of length of stay), or died in hospital. Logistic regression analysis was performed to assess independent predictors for in-hospital mortality. p<0.05 was considered statistically significant. RESULTS: We included 331 patients, 199 (60.1%) boys/132 girls with a median age of 7 years and injury severity score (ISS) of 9. A total of 307/331 (92.7%) survived to discharge, and 16/24 (66.7%) deaths occurred within 24h after admission. Age was significantly lower in patients dying due to trauma (median 5 (0-15) vs. 7 (0-15) years, p=0.04, adjusted odds ratio (OR)=0.89 [95% CI: 0.80-0.99]). ISS was significantly higher in patients who died (median 25 (16-71) vs. 9 (4-29), p<0.0001, adjusted OR=1.15 [95% CI: 1.10-1.20]). CONCLUSIONS: Children who did not survive after severe trauma were significantly younger, more injured, and died early after admission.