Chloral hydrate enteral infusion for sedation in ventilated children: the CHOSEN pilot study.
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ABSTRACT: We aimed to test a novel method of delivery of chloral hydrate (CH) sedation in ventilated critically ill young children.Children?RESULTSThere 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.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.
<h4>Background</h4>We aimed to test a novel method of delivery of chloral hydrate (CH) sedation in ventilated critically ill young children.<h4>Methods</h4>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 ...[more]
Project description:BackgroundPhysiological processes influencing a drugs' efficacy change substantially over the course of the day. However, it is unclear whether there is an association between the sedative success rate of chloral hydrate and the time of day. We conducted a retrospective study of 41,831 cases, to determine if there was a difference in sedation success rate with chloral hydrate in children seen in the morning and afternoon.MethodsPatients who accepted the sedation service were included. Eligible patients were divided into two cohorts of morning and afternoon cases, according to the time of day when the initial dose of chloral hydrate was administered. To ensure that the two groups were comparable, a propensity score matching method was utilized.ResultsThe success rate with the initial dose of chloral hydrate was higher in patients who received sedation services in the afternoon. In the subgroup analysis, the afternoon cases had a higher sedation success rate compared to the morning cases in male patients; whereas, in female patients, no difference was detected between the morning versus afternoon cases.ConclusionsThese results show that the afternoon cases had a higher sedation success rate than the morning cases, despite the afternoon cases receiving relatively lower initial dose than the morning cases. However, the clinical significance remains to be discussed, and further prospective studies are needed to validate the findings.
Project description:BackgroundOral chloral hydrate is widely used in pediatric sedation. Intranasal dexmedetomidine has been increasingly used for pediatric sedation; however, its improvement is warranted. The combination of dexmedetomidine with ketamine can improve onset and hemodynamic stability while maintaining sedative efficacy. This study aims to determine the efficacy and safety of intranasal combination of dexmedetomidine and ketamine compared to oral chloral hydrate.MethodsThis is a prospective, parallel-arm, single-blinded, two-center, superiority randomized controlled trial with 1:1 allocation, designed to compare the effects of intranasal combination of dexmedetomidine and ketamine with those of oral chloral hydrate. We shall enroll 136 patients aged < 7 years old in this study. Prior to the procedure, we shall randomize each patient into the control group (oral chloral hydrate 50 mg/kg) or study group (intranasal dexmedetomidine 2 μg/kg and ketamine 3 mg/kg). The primary outcome will be the rate of achieving an adequate sedation level (6-point Pediatric Sedation State Scale 1, 2, or 3) within 15 min. In addition, we shall measure the sedation time, sedation failure rate, completion of procedure, adverse events, patient acceptance, and physician satisfaction.DiscussionThis study will provide evidence of the efficacy and safety of the intranasal combination of dexmedetomidine and ketamine in comparison with oral chloral hydrate.Trial registrationClinicalTrials.gov , NCT04820205. Registered on 19th March 2021.
Project description:Study objectiveIn Asian countries, oral chloral hydrate is the most commonly used sedative for non-invasive procedures. Theoretically, mild sleep deprivation could be considered as one of assisted techniques. However, there is no consensus on sleep deprivation facilitating the sedation during non-painful procedures in children. The aim of our study is to analyze the clinical data of children undergoing non-invasive procedural sedation retrospectively and to evaluate the association between mild sleep deprivation and sedative effects in non-invasive procedures.MeasurementsConsecutive patients undergoing chloral hydrate sedation for non-invasive procedures between December 1, 2019 to June 30, 2020 were included in this study. The propensity score analysis with 1: 1 ratio was used to match the baseline variables between patients with sleep deprivation and non-sleep deprivation. The primary outcome was the failure rate of sedation with the initial dose. The secondary outcomes included the failure rate of sedation after supplementation of chloral hydrate, the incidence of major and minor adverse events, initial and supplemental dose of chloral hydrate, and the length of sedation time.Main resultsOf the 7789 patients undergoing chloral hydrate sedation, 6352 were treated with sleep deprivation and 1437 with non-sleep deprivation. After propensity score matching, 1437 pairs were produced. The failure rate of sedation with initial chlorate hydrate was not significantly different in two groups (8.6% [123/1437] vs. 10.6% [152/1437], p = 0.08), nor were the failure rates with supplemental chlorate hydrate (0.8% [12/1437] vs. 0.9% [13/1437], p = 1) and the length of sedation time (58 [45, 75] vs. 58 [45, 75] min; p = 0.93).ConclusionsThe current results do not support sleep deprivation have a beneficial effect in reducing the pediatric chloral hydrate sedation failure rate. The routine use of sleep deprivation for pediatric sedation is unnecessary.
Project description:ObjectiveThis meta-analysis aims to evaluate the sedative efficacy and safety of intranasal administration of dexmedetomidine (DEX) compared with oral chloral hydrate for Computed tomography (CT) or Magnetic Resonance Imaging (MRI) examination in Children.MethodsCochrane Library, PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), and China WanFang Databases were searched to collect randomized controlled trials (RCTs) investigating intranasal DEX (test group) vs. oral chloral hydrate (control group) in pediatric CT/MRI examinations up to December 30, 2021. The data were analyzed using Stata 15.0 software.ResultsSeven RCTs with 1,846 children were identified. The meta-analysis results showed that the success rate of sedation (RR = 1.14, 95% CI: 1.03-1.26, P = 0.011), sedation onset time [weighted mean difference (WMD) = -0.87, 95% CI: -1.42 to -0.31, P = 0.002], sedation duration (WMD = -9.05, 95% CI:-14.69 to -3.42, P = 0.002), time to awakening (WMD = -9.75, 95% CI:-17.57 to -1.94, P = 0.014), and incidence of nausea and vomiting [relative risk (RR) = 0.09, 95% CI:0.04-0.23, P < 0.001) of the test group were significantly better than those of the control group. However, no significant differences were identified in incidence of hypotension (RR = 1.18, 95% CI: 0.51-2.74) and bradycardia (RR = 1.17, 95% CI: 0.13-22.11) between the two groups.ConclusionIntranasal administration of DEX is superior to oral chloral hydrate for sedation during pediatric CT/MRI examinations and has a better safety profile.
Project description:BackgroundTo evaluate the efficacy and safety of rectal chloral hydrate (CH) in pediatric procedural sedation.MethodsSeven electronic databases and 3 clinical trials registry platforms were searched, and the deadline was August 2022. Randomized controlled trials evaluating the efficacy and safety of rectal CH in pediatric procedural sedation were included by 2 reviewers. The extracted outcomes included the success rate of sedation, sedation latency, sedation duration, and adverse events. The Cochrane risk of bias tool was used to assess the risk of bias. The outcomes were analyzed using Review Manager 5.3 software.ResultsForty-four randomized controlled trials with 8007 children were included in the meta-analysis. The success rate of sedation in the rectal CH group was significantly higher than that in the placebo group (risk ratio [RR], 2.60 [95% confidence interval [CI], 1.74-3.89]; P < .01; RR, 1.24 [95% CI, 1.01-1.54]; P = .04), oral CH group (RR, 1.12 [95% CI, 1.09-1.14]; I2 = 36%; P < .001; number needed to treat [NNT] = 10), diazepam group (RR, 1.21 [95% CI, 1.10-1.33]; I2 = 0%; P < .001; NNT = 6), phenobarbital group (RR, 1.24 [95% CI, 1.13-1.35]; I2 = 12%; P < .001; NNT = 6), and ketamine group (RR, 1.39 [95% CI, 1.20-1.60]; I2 = 20%; P < .001; NNT = 5). There was no significant difference in the success rate of sedation between the rectal CH group and the midazolam group (RR, 0.98 [95% CI, 0.86-1.11]; I2 = 51%; P > .05). The sedation latency was significantly shorter in rectal CH group than that in the oral CH group (mean difference [MD], -6.36 [95% CI, -7.04 to -5.68]; I2 = 49%; P < .001) and the phenobarbital group (MD, -7.64 [95% CI, -9.12 to -6.16]; P < .00001). The sedation duration in the rectal CH group was significantly longer than in the oral CH group (MD, 6.43 [95% CI, 4.39-8.47]; I2 = 0%; P < .001). The overall incidence of adverse events was significantly lower with rectal CH than with oral CH (RR, 0.21 [95% CI, 0.16-0.29]; I2 = 45%; P < .001) and ketamine (RR, 0.26 [95% CI, 0.12-0.60]; I2 = 0%; P = .001). There was no significant difference in the overall incidence of adverse events with rectal CH compared with intramuscular midazolam (RR, 0.55 [95% CI, 0.23-1.28]; P = .17) and intranasal midazolam (RR, 3.00 [95% CI, 0.66-13.69]; P = .16).ConclusionThe available evidence suggests that rectal CH cloud be an effective and safe sedative agent for pediatric procedural sedation.
Project description:This study evaluates the safety and efficacy of chloral hydrate administration for the conscious sedation of infants in the pediatric cardiovascular intensive care unit (PCICU).We conducted a retrospective review of the charts of 165 infants with congenital heart disease who received chloral hydrate in our PCICU between January 2014 and December 2014. Chloral hydrate was administered orally or rectally to infants using doses of 50 mg/kg. We collected and analyzed relevant clinical parameters.The overall length of time to achieve sedation was ranged from 5 to 35 min (10.8 ± 6.2 min); the overall mean duration of sedation was ranged from 15 to 60 min (33.5 ± 11.3 min); and the overall mean length of time to return to normal activity was 10 min to 6 h (34.3 ± 16.2 min). The length of the PCICU stay was ranged from 3 to 30 days (8.2 ± 7.1 days). Physiologically, there were no clinically significant changes in heart rate, mean arterial pressure, respiratory rate, or peripheral oxygen saturation before, during, or after use of the chloral hydrate. There were no significant differences regarding sedative effects in the subgroups (cyanotic vs acyanotic group, with pulmonary infection vs without pulmonary infection group, and with pulmonary hypertension vs without pulmonary hypertension group).Our experience suggests that chloral hydrate is a safe and efficacious agent for conscious sedation of infants in the PCICU.
Project description:Assessing and managing pain and agitation in critically ill children can be challenging. Multiple factors contribute to the challenges of management, including prior medication exposure, surgical and procedural interventions, pharmacokinetics, and age-related pharmacodynamics making the population heterogeneous. Therefore, individualizing treatment approaches embedded with frequent assessments is likely to improve the management of pain and agitation in critically ill children. Novel approaches to manage pain and agitation continue to evolve and will require ongoing evaluation prior to widespread adoption.
Project description:BackgroundWe documented previously the entity of trichloroethylene (TCE) hypersensitivity syndrome (THS) in occupational workers.ObjectivesTo identify the culprit causative compound, determine the type of hypersensitivity of THS, and establish a screening test for subjects at risk of THS.MethodsTCE and its main metabolites chloral hydrate (CH), trichloroethanol (TCOH) and trichloroacetic acid (TCA) were used as allergens at different concentrations in skin patch tests. The study included 19 case subjects diagnosed with occupational THS, 22 control healthy workers exposed to TCE (exposure >12 weeks), and 20 validation new workers exposed to TCE for <12 weeks free of THS. All subjects were followed-up for 12 weeks after the patch test.ResultsThe highest patch test positive rate in subjects with THS was for CH, followed by TCOH, TCA and TCE. The CH patch test positive rate was 100% irrespective of CH concentrations (15%, 10% and 5%). The TCOH patch test positive rate was concentration-dependent (89.5%, 73.7% and 52.6% for 5%, 0.5% and 0.05%, respectively). Lower patch test positive rates were noted for TCA and TCE. All patch tests (including four allergens) were all negative in each of the 22 control subjects. None of the subjects of the validation group had a positive 15% CH patch test.ConclusionsChloral hydrate seems to be the culprit causative compound of THS and type IV seems to be the major type of hypersensitivity of THS. The CH patch test could be potentially useful for screening workers at risk of THS.
Project description:Urine can be a better source than blood for biomarker discovery since it accumulates many changes. The urine proteome is susceptible to many factors, including anesthesia. Pentobarbital sodium and chloral hydrate are commonly used anesthetics in animal experiments. This study demonstrated the effects of these two anesthetics on the rat urine proteome using liquid chromatography-tandem mass spectrometry (LC-MS/MS). With anesthesia, the urinary protein-to-creatinine ratio of all rats increased twofold. The relative abundance of 22 and 23 urinary proteins were changed with pentobarbital sodium or chloral hydrate anesthesia, respectively, as determined by label-free quantification. Among these changed proteins, fifteen had been considered as candidate biomarkers such as uromodulin, and sixteen had been considered stable in healthy human urine, which are more likely to be considered as potential biomarkers when changed, such as transferrin. The pattern of changed urinary proteins provides clues to the discovery of urinary proteins regulatory mechanisms. When determining a candidate biomarker, anesthetic-related effects can be excluded from future biomarker discovery studies. Since anesthetics take effects via nervous system, this study is the first to provide clues that the protein handling function of the kidney may possibly be regulated by the nervous system.