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.

Cost-effectiveness analysis of clinic-based chloral hydrate sedation versus general anaesthesia for paediatric ophthalmological procedures.

BACKGROUND/AIMS: The inability of some children to tolerate detailed eye examinations often necessitates general anaesthesia (GA). The objective was to assess the incremental cost effectiveness of paediatric eye examinations carried out in an outpatient sedation unit compared with GA. METHODS: An episode of care cost-effectiveness analysis was conducted from a societal perspective. Model inputs were based on a retrospective cross-over cohort of Canadian children aged <7 years who had both an examination under sedation (EUS) and examination under anaesthesia (EUA) within an 8-month period. Costs ($CAN), adverse events and number of successful procedures were modelled in a decision analysis with one-way and probabilistic sensitivity analysis. RESULTS: The mean cost per patient was $406 (95% CI $401 to $411) for EUS and $1135 (95% CI $1125 to $1145) for EUA. The mean number of successful procedures per patient was 1.39 (95% CI 1.34 to 1.42) for EUS and 2.06 (95% CI 2.02 to 2.11) for EUA. EUA was $729 more costly on average than EUS (95% CI $719 to $738) but resulted in an additional 0.68 successful procedures per child. The result was robust to varying the cost assumptions. CONCLUSIONS: Cross-over designs offer a powerful way to assess costs and effectiveness of two interventions because patients serve as their own control. This study demonstrated significant savings when ophthalmological exams were carried out in a hospital outpatient clinic, although with slightly fewer procedures completed.

Pain score assessment in babies undergoing laser treatment for retinopathy of prematurity under sub-tenon anaesthesia.

PURPOSE: To assess the tolerability and outcomes of laser treatment for retinopathy of prematurity (ROP) under sub-tenon anaesthetic with oral or rectal sedation using a reliable, multidimensional, and internationally accepted tool for assessment of neonatal pain. METHODS: Sixty-two babies have had ROP laser treatment in our neonatal unit in the 7-year interval between 1 March 2005 and 28 February 2012; 44% (27 of the 62) were performed using sub-tenon anaesthesia. Pain scores were routinely assessed using the Neonatal Pain Agitation and Sedation Scale (N-PASS) every 10 min during laser treatment. The outcome and requirement for re-treatment in this group was compared with that in the intravenous sedation group. RESULTS: Pain scores were available in 19 of the 27 babies treated under sub-tenon anaesthesia. The mean pain score during treatment was 2.7 (SD ± 1.7, range 0.5-6.2). There was no statistically significant correlation between the mean pain score and duration of treatment (Spearman correlation coefficient (ρ) = 0.31; P = 0.09), number of laser burns (ρ = 0.32; P = 0.09), or post-menstrual age of the baby at the time of treatment (ρ = 0.38; P = 0.052). Treatments performed under sub-tenon anaesthesia were as successful as those performed under intravenous sedation. The mean pain scores during laser treatment under sub-tenon anaesthesia in our study were lower than those previously reported during ROP screening or heel-stick procedure.Conclusion Our study demonstrated that sub-tenon anaesthesia with oral or rectal sedation provides sufficient pain control for laser treatment for ROP without the need or risks of intravenous sedation and intubation.

Moderate sedation for echocardiography of preschoolers.

Preschoolers frequently require sedation for echocardiograms. This study compared various sedation drugs at the authors' institution, as well as the charges for moderate versus deep sedation. From 2001 to 2007, sedation was administered to 703 patients ages 2 to 4 years. Four drug regimens were used: chloral hydrate (CH), chloral hydrate with diphenhydramine (CH + D), chloral hydrate with hydroxyzine hydrochloride (CH + H), and midazolam. The mean onset of sedation was 37 min, and the mean duration of sedation was 47 min. The CH group fell asleep the most quickly (30 min; p < 0.001), and the CH + D patients experienced the most prolonged sedations (13%; p < 0.001). Studies were completed by 97% of the chloral hydrate group, 98% of the CH + D group, and 94% of the CH + H group compared with 66% of the midazolam group (p < 0.001). Complications (7.4%) were minor and not significant for any particular medication. The charges for moderate sedation averaged $709 compared with $3,628 for deep sedation. The findings demonstrated that chloral hydrate was the fastest-acting agent and had a high success rate with minimally prolonged sedations. The low complication rate for chloral hydrate, and the much lower cost for its use to induce moderate sedation have made chloral hydrate our preference for the echocardiographic sedation of preschoolers.

Sleep/sedation in children undergoing EEG testing: a comparison of chloral hydrate and music therapy.

This study included a total of 60 pediatric patients ranging from 1 month through 5 years of age. The effects of chloral hydrate and music therapy were evaluated and compared as means of safe and effective ways to achieve sleep/sedation in infants and toddlers undergoing EEG testing. The results of the study indicate that music therapy may be a cost-effective, risk-free alternative to pharmacological sedation.

Sedation in pediatric dentistry: a practical assessment procedure.

An assessment model for evaluating sedation in pediatric dental patients has been described. The model in whole or in part can be a valuable asset in drug trials and clinical evaluations. The unique characteristics of this model include: assessments are easily and quickly carried out without interruption of normal patient care; the criteria for sedation behavior can be standardized and are clinically relevant; a determination of the level of consciousness using an airway obstruction maneuver permits an assessment of safety; and the reliability of the observer ratings is extremely high, thereby avoiding the necessity of specially trained personnel. Using the assessment procedure, a placebo-controlled, double-blind clinical trial of various doses of chloral hydrate with and without N2O was performed. The results indicate that: children receiving the placebo treatment behaved favorably for at least 46% of the ratings; the 20 mg/kg and 40 mg/kg chloral hydrate groups showed little or no improvement when compared with the placebo group; the group receiving 60 mg/kg chloral hydrate had as much as a 33% improvement in behavior as compared with placebo; and with the addition of 40% N2O/60% O2 to 60 mg/kg chloral hydrate premedication, four of 15 children (27%) were unable to maintain a patent airway when intentionally obstructed.

Clinical experience with auditory brainstem response audiometry in pediatric assessment.

We discuss our experience with evaluation of 167 children by auditory brainstem response audiometry in 1978. We summarize experience with referral sources, medication for sedation, and interpretation of test outcome. Medication for sedation was required for 136 children. Concommitant central nervous system involvement rendered auditory brainstem response ambiquous in some children; however, the technique still provide useful information about status of peripheral auditory sensitivity obtainable in no other way. Finally, agreement among auditory brainstem response, behavioral, and impedance audiometry predictions was usually quite good.