Pragmatic sedation strategies to prevent secondary brain injury in low-resource settings.

Traumatic brain injury is the alteration in brain function due to an external force. It is common and affects millions of people worldwide annually. The World Health Organization estimates that 90% of global deaths caused by injuries occur in low- and middle-income countries, with traumatic brain injury contributing up to half of these trauma-related deaths. Patients with traumatic brain injury in low- and middle-income countries have twice the odds of dying compared with their counterparts in high-income countries. Sedation is a key element of care in the management of traumatic brain injury, used for its neuroprotective effects and to prevent secondary brain injury. While sedatives have the potential to improve outcomes, they can be challenging to administer and have potentially dangerous complications. Sedation in low-resource settings should aim to be effective, safe, affordable and feasible. In this paper, we summarise the indications for sedation in traumatic brain injury, the choice of sedative drugs and the pragmatic management and monitoring of sedated traumatic brain injury patients in low-resource settings.

[Standardization of Hypnotic Agents for Prevention of Falls: A Pharmacoeconomic Study].

To reduce the number of falls caused by hypnotic agents, the standardization of insomnia treatment was carried out at Yamaguchi University Hospital from April 2019. There were concerns that medical costs would increase due to the selected medicines-suvorexant and eszopiclone-being more expensive than conventional benzodiazepines. In this study, the standardization of insomnia treatment was evaluated by pharmacoeconomics. The costs of the hypnotic agents was considered, as was the cost of examination/treatment following falls. Effectiveness was evaluated as the incidence of falls within 24 hours of taking hypnotic agents. This analysis took the public healthcare payer's perspective. Propensity score matching based on patient background, showed that, per hospitalization the medicine costs of the recommended group increased by 1,020 yen, however, the examination/treatment costs following falls decreased by 487 yen when compared with the non-recommended group. Overall, the recommended group incurred costs of 533 yen more per hospitalization for patients prescribed hypnotic agents compared to the non-recommended group, but the incidence of falls for the recommended group was significantly lower than that in the non-recommended group (1.9% vs. 6.3%; p<0.01). These results suggest that in order to prevent the incidence of falls by 1 case, it is necessary to increase costs by 12,086 yen which is the subthreshold cost for switching to the recommended medicine as standardization. The selection of recommended medicines may be a cost-effectiveness option compared with non-recommended medicines.

Cost-Effectiveness of Propofol (Diprivan) Versus Inhalational Anesthetics to Maintain General Anesthesia in Noncardiac Surgery in the United States.

OBJECTIVES: It is not known whether using propofol total intravenous anaesthesia (TIVA) to reduce incidence of postoperative nausea and vomiting (PONV) is cost-effective. We assessed the economic impact of propofol TIVA versus inhalational anesthesia in adult patients for ambulatory and inpatient procedures relevant to the US healthcare system. METHODS: Two models simulate individual patient pathways through inpatient and ambulatory surgery with propofol TIVA or inhalational anesthesia with economic inputs from studies on adult surgical US patients. Efficacy inputs were obtained from a meta-analysis of randomized controlled trials. Probabilistic and deterministic sensitivity analyses assessed the robustness of the model estimates. RESULTS: Lower PONV rate, shorter stay in the post-anesthesia care unit, and reduced need for rescue antiemetics offset the higher costs for anesthetics, analgesics, and muscle relaxants with propofol TIVA and reduced cost by 11.41 ± 10.73 USD per patient in the inpatient model and 11.25 ± 9.81 USD in the ambulatory patient model. Sensitivity analyses demonstrated strong robustness of the results. CONCLUSIONS: Maintenance of general anesthesia with propofol was cost-saving compared to inhalational anesthesia in both inpatient and ambulatory surgical settings in the United States. These economic results support current guideline recommendations, which endorse propofol TIVA to reduce PONV risk and enhance postoperative recovery.

Economic Evaluation of Sedative Deprescribing in Older Adults by Community Pharmacists.

BACKGROUND: Sedative use in older adults increases the risk of falls, fractures, and hospitalizations. The D-PRESCRIBE (Developing Pharmacist-Led Research to Educate and Sensitize Community Residents to the Inappropriate Prescriptions Burden in the Elderly), pragmatic randomized clinical trial demonstrated that community-based, pharmacist-led education delivered simultaneously to older adults and their primary care providers reduce the use of sedatives by 43% over 6 months. However, the associated health benefits and cost savings have yet to be described. This study evaluates the cost-effectiveness of the D-PRESCRIBE intervention compared to usual care for reducing the use of potentially inappropriate sedatives among older adults. METHODS: A cost-utility analysis from the public health care perspective of Canada estimated the costs and quality-adjusted life-years (QALYs) associated with the D-PRESCRIBE intervention compared to usual care over a 1-year time horizon. Transition probabilities, intervention effectiveness, utility, and costs were derived from the literature. Probabilistic analyses were performed using a decision tree and Markov model to estimate the incremental cost-effectiveness ratio. RESULTS: Compared to usual care, pharmacist-led deprescribing is less costly (-$1392.05 CAD) and more effective (0.0769 QALYs). Using common willingness-to-pay (WTP) thresholds of $50 000 and $100 000, D-PRESCRIBE was the optimal strategy. Scenario analysis indicated the cost-effectiveness of D-PRESCRIBE is sensitive to the rate of deprescribing. CONCLUSIONS: Community pharmacist-led deprescribing of sedatives is cost-effective, leading to greater quality-of-life and harm reduction among older adults. As the pharmacist's scope of practice expands, consideration should be given to interprofessional models of remuneration for quality prescribing and deprescribing services.

Effects of pain, sedation and delirium monitoring on clinical and economic outcome: A retrospective study.

BACKGROUND: Significant improvements in clinical outcome can be achieved by implementing effective strategies to optimise pain management, reduce sedative exposure, and prevent and treat delirium in ICU patients. One important strategy is the monitoring of pain, agitation and delirium (PAD bundle). We hypothesised that there is no sufficient financial benefit to implement a monitoring strategy in a Diagnosis Related Group (DRG)-based reimbursement system, therefore we expected better clinical and decreased economic outcome for monitored patients. METHODS: This is a retrospective observational study using routinely collected data. We used univariate and multiple linear analysis, machine-learning analysis and a novel correlation statistic (maximal information coefficient) to explore the association between monitoring adherence and resulting clinical and economic outcome. For univariate analysis we split patients in an adherence achieved and an adherence non-achieved group. RESULTS: In total 1,323 adult patients from two campuses of a German tertiary medical centre, who spent at least one day in the ICU between admission and discharge between 1. January 2016 and 31. December 2016. Adherence to PAD monitoring was associated with shorter hospital LoS (e.g. pain monitoring 13 vs. 10 days; p<0.001), ICU LoS, duration of mechanical ventilation shown by univariate analysis. Despite the improved clinical outcome, adherence to PAD elements was associated with a decreased case mix per day and profit per day shown by univariate analysis. Multiple linear analysis did not confirm these results. PAD monitoring is important for clinical as well as economic outcome and predicted case mix better than severity of illness shown by machine learning analysis. CONCLUSION: Adherence to PAD bundles is also important for clinical as well as economic outcome. It is associated with improved clinical and worse economic outcome in comparison to non-adherence in univariate analysis but not confirmed by multiple linear analysis. TRIAL REGISTRATION: clinicaltrials.gov NCT02265263, Registered 15 October 2014.

Clinical and economic impact of the use of dexmedetomidine for sedation in the intensive care unit compared to propofol.

Background Despite the advantages of dexmedetomidine (DEX) over propofol (PRO) including minimal respiratory depression and the potential for preventing and/or treating intensive care unit (ICU) delirium, PRO has been the preferred agent due to its lower cost. However, the acquisition cost of DEX has considerably decreased as a generic version of DEX has recently become available. Objective To evaluate clinical and economic outcomes of DEX-based sedation compared to PRO in the ICU. Setting A retrospective cohort study of 86 ICU patients who received either DEX or PRO for a period ≥ 12 h. Method Patients were matched by age, sex, and Sequential Organ Failure Assessment scores in a 1:1 ratio. Main outcome measure Clinical outcomes included the duration of mechanical ventilation (MV), ICU and hospital length of stay (LOS), and requirements of concomitant sedatives and opioids. Economic outcomes included the ICU and hospital costs as well as the cost of sedatives or combined sedatives and opioids per patient. Results There were no significant differences in ICU and hospital LOS and time on MV in both groups (median ICU LOS 7 [DEX] vs. 9 [PRO] days, p = 0.07; median hospital LOS 12 [DEX] vs. 14 [PRO] days, p = 0.261; median time of MV 144 [DEX] vs. 158 [PRO] hours, p = 0.176). DEX-based sedation compared to PRO was associated with similar ICU and hospital costs (US$ 67,561 vs. 78,429, p = 0.39; US$ 71,923 vs. 71,084, p = 0.1). Conclusion The clinical outcomes and economic impact associated with DEX- and PRO-based sedation were similar.

Procedural sedation for direct current cardioversion: a feasibility study between two management strategies in the emergency department.

BACKGROUND: A cardiologist-only approach to procedural sedation with midazolam in the setting of elective cardioversion (DCC) for AF has already been proven as safe as sedation with propofol and anaesthesiologist assistance. No data exist regarding the safety of such a strategy during emergency procedures. The aim of this study is to compare the feasibility of sedation with midazolam, administered by a cardiologist, to an anaesthesiologist-assisted protocol with propofol in emergency DCC. METHODS: Single centre, prospective, open blinded, randomized study including all consecutive patients admitted to the Emergency Department requiring urgent or emergency DCC. Patients were randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the midazolam group were managed by the cardiologist only, while patients treated with propofol group underwent DCC with anaesthesiologist assistance. RESULTS: Sixty-nine patients were enrolled and split into two groups. Eighteen patients (26.1%) experienced peri-procedural adverse events (bradycardia, severe hypotension and severe hypoxia), which were similar between the two groups and all successfully managed by the cardiologist. No deaths, stroke or need for invasive ventilation were registered. Patients treated with propofol experienced a greater decrease in systolic and diastolic blood pressure when compared with those treated with midazolam. As the procedure was shorter when midazolam was used, the median cost of urgent/emergency DCC with midazolam was estimated to be 129.0 € (1st-3rd quartiles 114.6-151.6) and 195.6 € (1st-3rd quartiles 147.3-726.7) with propofol (p < .001). CONCLUSIONS: Procedural sedation with midazolam given by the cardiologist alone was feasible, well-tolerated and cost-effective in emergency DCC.

Medical, Political, and Economic Considerations for the Use of MAC for Endoscopic Sedation: Big Price, Little Justification?

The last few decades of gastrointestinal (GI) endoscopy have seen phenomenal growth. In many aspects, GI endoscopy has led the field of nonsurgical interventional medicine. In many aspects, this growth is facilitated by advancements in sedation-both drugs and techniques. Unfortunately, the topic of GI endoscopy sedation is also mired in many controversies, mainly emanating from the cost of anesthesia providers. While no one debates their role in the majority of advanced endoscopic procedures, the practice of universal propofol sedation in the USA, delivered by anesthesia providers, needs a closer look. In this review, medical, political, and economic considerations of this important topic are discussed in a very frank and honest way. While such ubiquitous propofol use has increased satisfaction of both patients and gastroenterologists, there is little justification. More importantly, going by the evidence, there is even less justification for the mandated anesthesia providers use for such delivery. Unfortunately, the FDA could not be convinced otherwise. The new drug fospropofol met the same fate. Approval of SEDASYS®, the first computer-assisted personalized sedation system, was a step in the right direction, nevertheless an insufficient step that failed to takeoff. As a result, in spite of years of research and efforts of many august societies, the logjam of balancing cost and justification of propofol sedation has continued. We hope that recent approval of remimazolam, a novel benzodiazepine, and potential approval of oliceridine, a novel short-acting opioid, might be able to contain the cost without compromising the quality of sedation.

Patient-controlled sedation with propofol for endoscopic procedures-A cost analysis.

BACKGROUND: Patient-controlled sedation (PCS) with propofol accompanied by a bedside nurse anaesthetist is an alternative sedation method for endoscopic procedures compared with midazolam administered by a nurse or endoscopist. Increasing costs in health care demands an economic perspective when introducing alternative methods. We applied a hospital perspective on a cost analysis comparing different methods of sedation and the resource use that were expected to affect cost differences related to the sedation. METHODS: Based on two randomised previous studies, the direct costs were determined for different sedation methods during two advanced endoscopic procedures: endoscopic retrograde cholangiopancreatography (ERCP) and flexible bronchoscopy including endobronchial ultrasound. ERCP comparisons were made between midazolam sedation by the endoscopic team, PCS with a bedside nurse anaesthetist and propofol sedation administered by a nurse anaesthetist. Bronchoscopy comparisons were made between midazolam sedation by the endoscopic team and PCS with a bedside nurse anaesthetist, categorised by premedication morphine-scopolamine or glycopyrronium. RESULTS: Propofol PCS with a bedside nurse anaesthetist resulted in lower costs per patient for sedation for both ERCP (233 USD) and bronchoscopy (premedication morphine-scopolamine 267 USD, premedication glycopyrronium 269 USD) compared with midazolam (ERCP 425 USD, bronchoscopy 337 USD). Aborted procedures that needed to be repeated and prolonged hospital stays significantly increased the cost for the midazolam groups. CONCLUSION: Propofol PCS with a bedside nurse anaesthetist reduces the direct sedation costs for ERCP and bronchoscopy procedures compared with midazolam sedation.

Financial impact of an analgosedation protocol for mechanically ventilated patients in a cardiovascular intensive care unit.

PURPOSE: The primary objective was to evaluate the impact of an analgosedation protocol in a cardiac intensive care unit (CICU) on daily doses and costs of analgesic, sedative, and antipsychotic medications. METHODS: We conducted a single-center quasi-experimental study in 363 mechanically ventilated patients admitted to our CICU from March 1, 2011, to April 13, 2013. On March 1, 2012, an analgosedation protocol was implemented. Patients in the pre-implementation group were managed at the cardiologist's discretion, which consisted of a continuous sedative-hypnotic approach and opioids as needed. Patients in the implementation group were managed using this protocol. RESULTS: The mean ± S.D. per-patient doses (mg/day) of propofol, lorazepam, and clonazepam decreased with the use of an analgosedation protocol (propofol 132,265.7 ± 12,951 versus 87,980.5 ± 10,564 [p = 0.03]; lorazepam 10.5 ± 7.3 versus 3.3 ± 4.0 [p < 0.001]; clonazepam 9.9 ± 8.3 versus 1.1 ± 0.5 [p = 0.03]). The mean daily cost of propofol and lorazepam also significantly decreased (33.5% reduction in propofol cost [p = 0.03]; 69.0% reduction in lorazepam cost [p < 0.001]). The per-patient dose and cost of fentanyl (mcg/day) declined with analgosedation protocol use (fentanyl 2,274.2 ± 2317.4 versus 1,026.7 ± 981.4 [p < 0.001]; 54.8% decrease in fentanyl cost [p < 0.001]). CONCLUSION: The implementation of an analgosedation protocol significantly decreased both the use and cost of propofol, lorazepam, and fentanyl. Further investigation of the clinical impact and cost-effectiveness of a critical care consultation service with implementation of an analgosedation protocol is warranted in the CICU.

General practitioners' concepts on issuing out-of-pocket prescriptions for hypnotics and sedatives in Germany.

BACKGROUND: In Germany, almost 50% of prescriptions for benzodiazepines and drugs as Zolpidem and Zopiclone are as out-of-pocket (OOP) prescriptions-requiring patients to buy the drug at their own expense-although almost 90% of the population has statutory health insurance covering medication costs. OBJECTIVE: To understand why general practitioners (GPs) choose this prescribing method since needed medications are insurance covered, and unnecessary drugs should not be prescribed at all. METHODS: In this qualitative study, 17 semi-structured interviews with GPs were conducted, audio recorded and transcribed verbatim. Transcripts were analysed with grounded theory to extract a model explaining the described behaviour. RESULTS: Knowing the significant medical risks and insecurity about regulations makes GPs wish to avoid hypnotics and sedatives. They achieve this by 'Creating a barrier' (central phenomenon) and employing the strategy 'Using an out-of-pocket prescription', which not only generates costs for the patient but also reduces the physicians´ legal and financial accountability. The perceived patient type, expected problem duration and diagnosis influence the decision about the prescription form: patients with an alcohol or drug addiction or those with 'uncomplicated' insomnia are more likely to receive an OOP prescription. Patients with any psychiatric diagnosis will likely receive a statutory health insurance prescription. DISCUSSION: Current regulations do not provide guidance to GPs regarding hypnotics and sedatives. A clear regulatory framework and guidelines could possibly reduce physicians' defensive attitudes about these drugs and their use of OOP prescriptions. The approach to use OOP prescriptions as a barrier to reduce patients' medication use lacks evidence regarding effectiveness.

Operator-Directed Procedural Sedation in the Congenital Cardiac Catheterization Laboratory.

OBJECTIVES: The purpose of this study was to evaluate the association between the method of procedural sedation and outcomes for congenital cardiac catheterization procedures. BACKGROUND: The safety of operator-directed sedation (ODS) in the pediatric/congenital cardiac catheterization laboratory has been questioned. To our knowledge, the relative safety of ODS versus general anesthesia (GA) in these cases has not to date been critically evaluated. METHODS: A single-center retrospective cohort study was performed to compare the relative safety, cost, and times of catheterization procedures performed with ODS and those performed with GA from a cardiac anesthesiologist. The risk of adverse outcomes was compared using propensity-score-adjusted models. Using the same propensity score, procedure times and relative charges were also compared. RESULTS: Over the study period, 4,424 procedures in 2,547 patients were studied. Of these, 27% of cases were performed with ODS. ODS procedures were 70% diagnostic procedures, 17% device closure of patent ductus arteriosus, 5% balloon pulmonary valvuloplasty, and 3% pulmonary artery angioplasty. The risk of adverse event in adjusted models for ODS cases was significantly lower than in GA cases (odds ratio: 0.66; 95% confidence interval: 0.45 to 0.95; p = 0.03). Total room time and case time were also significantly shorter (p < 0.001). Professional (charge ratio: 0.88; p < 0.001) and hospital (charge ratio: 0.84; p < 0.001) charges for ODS cases were also lower than those for GA cases. CONCLUSIONS: This study demonstrates that clinical judgment can identify subjects in whom ODS is not associated with increased risk of adverse events. The use of ODS was associated with reduced case times and charges. In combination, these findings suggest that the selective use of ODS can allow for greater efficiency and higher value care without sacrificing safety.

Better Pairing Propofol Volume With Procedural Needs: A Propofol Waste Reduction Quality Improvement Project.

BACKGROUND AND OBJECTIVES: Propofol facilitates deep sedation without requiring intubation and is often used by infusion to maintain sedation. Variability in ordering and preparation strategies resulted in significant propofol volumes wasted at the conclusion of procedures in our clinic. With drug shortages now common, we designed a quality improvement initiative to reduce our propofol waste. METHODS: Data collection during the preintervention phase reflected current practice trends. Two propofol dosing tables (≥50 or <50 kg) were designed to estimate the volume of propofol infusion required for sedations spanning 15 to 180 minutes. Nurses prepared propofol infusions as directed by these tables. The primary outcome measure was reduction in waste when the infusion was prepared by standardized strategy versus usual practice. Balancing measures included occurrences of insufficient infusion volume and premature awakenings from deep sedation. Waste volumes were plotted and displayed chronologically in statistical process control charts for the clinic and individual providers. RESULTS: A total of 155 patients received a propofol infusion to maintain deep sedation. The preintervention phase included 77 patients, and the intervention phase included 78 patients. Special cause variation was achieved in the intervention phase. Median (interquartile range) propofol waste volume per procedure declined from 45.6 mL (24.3-71 mL) to 14.3 mL (9.6-19.4 mL), representing a 68% waste reduction. CONCLUSIONS: Using an internally derived systematic approach to ordering and preparing a propofol infusion, we reduced variability, reduced propofol waste, and created cost savings for our organization. This approach is tailorable to other infusions and clinical settings.

Outcomes of protocolised analgesia and sedation in a neurocritical care unit.

OBJECTIVES: Providing analgesia and sedation while allowing for neurological assessment is important in the neurocritical care unit (NCCU), yet data are limited about the effects of protocolised analgesia and sedation. We developed an analgesia-based sedation protocol and evaluated its effect on medication utilisation and costs in the NCCU. METHODS: We conducted a retrospective cohort study of patients who are mechanically ventilated and admitted to a 12-bed NCCU over four years. To compare outcomes, we used gamma and negative binomial regression models, and interrupted time-series sensitivity analyses. RESULTS: The study cohort consisted of 1197 patients: 576 pre-protocol and 621 post-protocol. The protocol resulted in an increase in fentanyl use [incidence rate ratio (IRR) = 2.8, (95% confidence limits (CLs) 1.9, 4.2)] and a decrease in propofol use (IRR = 0.8, CLs 0.6, 1.0). There was a decrease in fentanyl (cost ratio = 0.8, CLs 0.5, 1.1) and propofol costs (cost ratio = 0.6, CLs 0.5, 0.8). The sensitivity analyses results were similar. There was no effect on healthcare utilisation, healthcare costs, and in-hospital mortality. CONCLUSION: Protocolised analgesia and sedation increased analgesia use, decreased sedative use, and reduced medication-associated costs in the NCCU. Our results suggest that similar NCCUs should consider use of population-specific protocols to manage analgesia and sedation.

Cost-effectiveness analysis of suvorexant for the treatment of Japanese elderly patients with chronic insomnia in a virtual cohort.

AIMS: This study assessed the cost-effectiveness of the orexin receptor antagonist suvorexant against zolpidem, the most widely used hypnotic benzodiazepine receptor agonist in Japan. To this end, a model was used that factored in insomnia and the risk for hip fractures, which have devastating effects on the elderly. METHODS: Data were derived from published papers. The target population was a virtual cohort of elderly patients (≥65 years) with insomnia residing in Japan. Cost-effectiveness was evaluated using quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio as effectiveness measures. The investigators assumed the perspective of healthcare payers. RESULTS: In the base-case analysis, suvorexant was cost-saving (suvorexant: $252.3, zolpidem: $328.7) and had higher QALYs gained (suvorexant: 0.0641, zolpidem: 0.0635) for elderly Japanese patients with insomnia compared with zolpidem, indicating that suvorexant was dominant. In the sensitivity analysis, the outcome changed from dominant to dominated due to the relative risk for hip fractures associated with suvorexant. However, when the other parameters were varied from the lower to the upper limits of their ranges, suvorexant remained dominant compared to zolpidem. LIMITATIONS: The relative risk for hip fractures for suvorexant used in the model was based on data from pre-approval clinical trials. More precise data may be needed. CONCLUSIONS: Suvorexant seemed to be more cost-effective than the alternative zolpidem. The findings suggested that suvorexant might be a viable alternative to zolpidem for elderly patients with insomnia. A sensitivity analysis showed that outcome varied depending on the relative risk for hip fractures associated with suvorexant. Further investigations may be needed for more precise results.

Purchases of prescription drugs before an alcohol-related death: A ten-year follow-up study using linked routine data.

BACKGROUND: Physician's intention to prescribe drugs could potentially be used to improve targeting of alcohol interventions and enhanced disease management to patients with a high risk of severe alcohol-related harm within outpatient settings. METHODS: Comparison of ten-year incidence trajectories of 13.8 million reimbursed purchases of prescription drugs among 303,057 Finnish men and women of whom 7490 ultimately died due to alcohol-related causes (Alc+), 14,954 died without alcohol involvement (Alc-), and 280,613 survived until the end of 2007. RESULTS: 5-10 years before death, 88% of the persons with an Alc+ death had received prescription medication, and over two-thirds (69%) had at least one reimbursed purchase of drugs for the alimentary tract and metabolism, the cardiovascular system, or the nervous system. Among persons with an Alc+ death, the incidence rate (IR) for purchases of hypnotics, and sedatives was 1.38 times higher (95% confidence interval (CI):1.32,1.44) compared to those with an Alc- death, and 4.07 times higher (95%CI:3.92,4.22) compared to survivors; and the IR for purchases of anxiolytics was 1.40 times higher (95%CI:1.34,1.47) compared to those with an Alc- death, and 3.61 times higher (95%CI:3.48,3.78) compared to survivors. CONCLUSIONS: Using physician's intention to prescribe drugs affecting the alimentary tract and metabolism, cardiovascular system and nervous system could potentially be used to flag patients who might benefit from screening, targeted interventions or enhanced disease management. In particular, patients who are to be prescribed anxiolytics, hypnotics, and sedatives, and antidepressants may benefit from enhanced interventions targeted to problem drinking.

Sedative and Analgesic Drugs Online: A Content Analysis of the Supply and Demand Information Available in Thailand.

BACKGROUND: Evidence from other countries has suggested that many controlled drugs are also offered online, even though it is illegal to sell these drugs without a license. OBJECTIVES: To evaluate the current contents related to the supply and demand of sedatives and analgesic drugs available online in Thailand, with a particular focus on Facebook. METHODS: A team of reviewers manually searched for data by entering keywords related to analgesic drugs and sedatives. The contents of the website were screened for supply and demand-related information. FINDINGS: A total of 5,352 websites were found publicly available. The number of websites and Facebook pages containing the information potentially related to the supply and demand of analgesic drugs and sedatives was limited. Nine websites sold sedatives, and six websites sold analgesics directly. Fourteen Facebook pages were found, including 7 sedative pages and 7 analgesic pages. Within one year, the three remaining active pages multiplied in the number of followers by three- to nine-fold. The most popular Facebook page had over 2,900 followers. CONCLUSIONS: Both the internet and social media contain sites and pages where sedatives and analgesics are illegally advertised. These websites are searchable through common search engines. Although the number of websites is limited, the number of followers on these Facebook pages does suggest a growing number of people who are interested in such pages. Our study emphasized the importance of monitoring and developing potential plans relative to the online marketing of prescription drugs in Thailand.

Chloral hydrate enteral infusion for sedation in ventilated children: the CHOSEN pilot study.

BACKGROUND: We aimed to test a novel method of delivery of chloral hydrate (CH) sedation in ventilated critically ill young children. METHODS: Children < 12 years old, within 72 hours of admission, who were ventilated, receiving enteral tube-feeds, with intermittent CH ordered were enrolled after signed consent. Patients received a CH loading-dose of 10 mg/kg enterally, then a syringe-pump enteral infusion at 5 mg/kg/hour, increasing to a maximum of 9 mg/kg/hour. Cases were compared to historical controls matched for age group and Pediatric Risk of Mortality score (PRISM) category, using Fisher's exact test and the t test. The primary outcome was feasibility, defined as the use of an enteral CH continuous infusion without discontinuation attributable to a pre-specified potential harm. RESULTS: There were 21 patients enrolled, at age 11.4 (12.1) months, with bronchiolitis in 10 (48%), a mean Pediatric Logistic Organ Dysfunction (PELOD) score of 6.2 (5.2), and having received enteral CH continuous infusion for 4.5 (2.2) days. Infusion of CH was feasible in 20/21 (95%; 95% CI 76-99%) patients, with one (5%) adverse event of duodenal ulcer perforation on day 3 in a patient with croup receiving regular ibuprofen and dexamethasone. The CH infusion dose (mg/kg/h) on day 2 (n = 20) was 8.9 (IQR 5.9, 9), and on day 4 (n = 11) was 8.8 (IQR 7, 9). Days to titration of adequate sedation (defined as ≤ 3 PRN doses/shift) was 1 (IQR 0.5, 2.5), and hours to awakening for extubation was 5 (IQR 2, 9). Cases (versus controls) had less positive fluid balance at 48 h (-2 (45) vs. 26 (46) ml/kg, p = 0.051), and a decrease in number of PRN sedation doses from 12 h pre to 12 hours post starting CH (4.7 (3.3) to 2.6 (2.8), p = 0.009 versus 2.9 (3.9) to 3.4 (5), p = 0.74). There were no statistically significant differences between cases and controls in inotrope scores, signs or treatment of withdrawal, or PICU days. CONCLUSIONS: Delivering CH by continuous enteral infusion is feasible, effective, and may be associated with less positive fluid balance. Whether there is a risk of duodenal perforation requires further study.