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Comparing the utility of a standard pediatric resuscitation cart with a pediatric resuscitation cart based on the Broselow tape: a randomized, controlled, crossover trial involving simulated resuscitation scenarios.

BACKGROUND: Access to resuscitation equipment is a critical component in delivering optimal care in pediatric arrest situations. Historically, children's hospitals and clinics have used a standard pediatric resuscitation cart ("standard cart") in which drawers are organized by intervention (eg, intubation module, intravenous module), requiring multiple drawers to be opened during a code. Many emergency departments, however, use a pediatric resuscitation cart based on the Broselow tape ("Broselow cart") in which each drawer is color coded and organized by patient length and weight ranges; each drawer contains all necessary equipment for resuscitation of a patient in that specific length/weight range. A literature review has revealed no studies examining the utility of either cart. OBJECTIVES: To compare which resuscitation cart organization (standard versus Broselow) allows for faster access to equipment, more accurate selection of appropriately sized equipment, and better user satisfaction. Methodology. We performed a prospective, randomized, controlled, crossover trial in which 21 pediatric health care providers were assigned the role of obtaining the appropriate equipment during 2 standardized, simulated codes alternately using either a standard or Broselow cart. Time to and accuracy of the selection of appropriate medical equipment along with posttesting satisfaction were measured. All simulations were performed in the Center for Advanced Pediatric Education at Stanford University Medical Center (Stanford, CA), a training facility designed to replicate the real medical environment with the technology to allow for videotaping of scenarios. RESULTS: Of the 21 subjects, 62% found the Broselow cart "easy" or "very easy" to use versus 33% for the standard cart. Of the 21 subjects, 67% preferred the Broselow cart, 10% preferred the standard cart, and 23% indicated no preference. Intubation supplies and nasogastric tubes were found significantly faster when using the Broselow cart (mean time: 29.1 and 20 seconds, respectively) versus the standard cart (mean time: 38.7 and 38.2 seconds, respectively). Correct equipment was provided a statistically significant 99% of the time with the Broselow cart versus 83% of the time with the standard cart. Ten percent of the subjects had prior experience with the Broselow cart versus 62% having experience with the standard cart. CONCLUSIONS: Despite less prior experience with the Broselow cart, subjects in this study found it easier to use and preferred it over the standard cart. In addition, subjects located intubation equipment and nasogastric tubes significantly faster when using the Broselow cart, and correct equipment was provided significantly more often with the Broselow cart. These data suggest that sites caring for pediatric patients should consider modeling their resuscitation carts after the Broselow cart to enhance provider confidence and patient safety.

Cardiopulmonary Resuscitation↗

Acetic acid-guided biopsies after magnifying endoscopy compared with random biopsies in the detection of Barrett's esophagus: a prospective randomized trial with crossover design.

BACKGROUND: In contrast to standard video endoscopy, magnifying endoscopy after local acetic acid application enables recognition of mucosal surface architecture. OBJECTIVE: To investigate the diagnostic yield of magnifying endoscopy with acetic acid-targeted biopsies compared to random, 4-quadrant biopsies. DESIGN: Prospective randomized trial (ratio 1:1) with crossover design. SETTING: Two referral hospitals in Germany. PATIENTS: Thirty-one patients with Barrett's esophagus or visible columnar-lined lower esophagus. INTERVENTIONS: Patients were randomized to undergo either standard video endoscopy with 4-quadrant biopsies or magnifying endoscopy in conjunction with acetic acid application. All patients were re-examined 14 days after the initial endoscopy with the corresponding procedure. MAIN OUTCOME MEASUREMENTS: Primary outcome analysis (per protocol and per biopsy) was the histological proof of Barrett's epithelium. Secondary outcome analysis was the correlation between the surface architecture and the presence of Barrett's epithelium and the needed number of biopsies to confirm Barrett's epithelium for the 2 different procedures. RESULTS: Magnifying endoscopy enabled the prediction of Barrett's epithelium with a sensitivity of 100% and a specificity of 66%, respectively (accuracy 83.8%). Acetic acid-guided biopsies obtained a significantly higher percentage of tissues containing SCE (78%; 188/241) compared to random biopsies (57%; 159/280). LIMITATIONS: No data on the diagnosis of Barrett's dysplasia. CONCLUSION: Magnifying endoscopy with acetic acid-guided biopsies is superior to standard video endoscopy with random biopsies, and the number of biopsies needed to confirm Barrett's epithelium is half as much when compared to random biopsies.

Acetic Acid↗

Electroacupuncture for tension-type headache on distal acupoints only: a randomized, controlled, crossover trial.

OBJECTIVE: To investigate the efficacy of electroacupuncture, applied to distal acupoints only, for tension-type headache. BACKGROUND: Electroacupuncture is commonly used for tension-type headache, but when applied to distal acupoints only, evidence of its efficacy is lacking. DESIGN: A randomized, single-blinded, sham-controlled, crossover clinical trial. Methods.-The trial had 5 stages: baseline (2 weeks), phases I and II (each 4 weeks), washout period (2 weeks), and follow-up (3 months after phase II). Forty patients were randomly assigned to either group A or group B. Group A received real electroacupuncture during phase I, then sham electroacupuncture in phase II. Group B received the treatments in reverse order. Outcome measures were headache frequency and duration, pain intensity using a visual analog scale, mechanical pain threshold, headache disability, and sickness impact. Data were analyzed by univariate 2-way analysis of variance. RESULTS: Thirty-seven patients completed the trial. There were no significant differences between the 2 groups at baseline. At the end of phase I, group A, but not group B, demonstrated significant improvement in mean (standard error of the mean [SEM]) headache frequency (3.0 per month [0.3] versus 12.0 per month [1.7]), duration (13.3 hours [3.5] versus 32.0 hours [6.2]), pain intensity (32.8 mm [4.1] versus 47.5 mm [2.7]), pain threshold (right side, 2.9 kg/second [0.1] versus 0.9 kg/second [0.1]; left side, 2.4 kg/second [0.1] versus 1.1 kg/second [0.1]), headache disability score (6.0 [1.0] versus 16.3 [1.6]), and sickness impact score (288.7 [48.0] versus 687.1 [77.2]). For each parameter, significant differences also were demonstrated for both groups between baseline and phase II, and baseline and follow-up. There were no significant differences between the groups at the end of follow-up (P >.05). CONCLUSION: Electroacupuncture to distal points alone is effective for short-term symptomatic relief of tension-type headache.

Acupuncture Points↗

A randomized controlled crossover trial of aspirin for fatigue in multiple sclerosis.

Pharmacotherapeutic options for multiple sclerosis (MS)-related fatigue are limited. Thirty patients were randomly assigned to aspirin (ASA) 1,300 mg/day or placebo in a double-blind crossover study. Results favored ASA for the main clinical outcomes: Modified Fatigue Impact Scale scores (p = 0.043) and treatment preference (p = 0.012). There were no significant adverse effects. The results warrant further study and support a role for ASA-influenced mechanisms, perhaps immunologic, in the generation of MS-related chronic fatigue.

Administration, Oral↗

Systems Analysis Reveals Contraceptive-Induced Alteration of Cervicovaginal Gene Expression in a Randomized Trial.

Hormonal contraceptives (HCs) are vital in managing the reproductive health of women. However, HC usage has been linked to perturbations in cervicovaginal immunity and increased risk of sexually transmitted infections. Here, we evaluated the impact of three HCs on the cervicovaginal environment using high-throughput transcriptomics. From 2015 to 2017, 130 adolescent females aged 15-19 years were enrolled into a substudy of UChoose, a single-site, open-label randomized, crossover trial (NCT02404038) and randomized to injectable norethisterone-enanthate (Net-En), combined oral contraceptives (COC), or etonorgesterol/ethinyl-estradiol-combined contraceptive vaginal ring (CCVR). Cervicovaginal samples were collected after 16 weeks of randomized HC use and analyzed by RNA-Seq, 16S rRNA gene sequencing, and Luminex analysis. Participants in the CCVR arm had a significant elevation of transcriptional networks driven by IL-6, IL-1, and NFKB, and lower expression of genes supporting epithelial barrier integrity. An integrated multivariate analysis demonstrated that networks of microbial dysbiosis and inflammation best discriminated the CCVR arm from the other contraceptive groups, while genes involved in epithelial cell differentiation were predictive of the Net-En and COC arms. Collectively, these data from a randomized trial represent the most comprehensive "omics" analyses of the cervicovaginal response to HCs and provide important mechanistic guidelines for the provision of HCs in sub-Saharan Africa.

HIV↗

Rapid onset of action of levodopa in restless legs syndrome: a double-blind, randomized, multicenter, crossover trial.

OBJECTIVE: To investigate the efficacy and safety of levodopa plus benserazide in the treatment of restless legs syndrome (RLS), in terms of the frequency of periodic limb movements (PLMs), objective and subjective criteria of sleep, onset of action, and withdrawal effects. DESIGN: A randomized, double-blind, placebo-controlled, multicenter, crossover trial, with two 4-week treatment periods. SETTING: Outpatient units of three specialist centers in Germany. PATIENTS: Eligible patients had to fulfill the diagnostic criteria of the International RLS Study Group and have sleep disturbances and PLMs during sleep shown on polysomnography at screening. Thirty-five patients were recruited, of whom 32 (13 men, 19 women) completed the study. INTERVENTIONS: Patients received a single dose of standard-release levodopa/benserazide 100/25 mg or placebo at bedtime each night for 4 weeks, before crossing over to receive the alternative treatment for a further 4 weeks; the dose could be doubled if required. The average dosages were 159 +/- 31 mg of levodopa and 1.56 +/- 0.29 capsules of placebo. RESULTS: Levodopa/benserazide significantly reduced the number of PLMs per hour (p<0.0001), increased the time in bed without limb movements (p<0.0001), and improved subjective quality of sleep (p=0.0004). The onset of action was rapid after the first dose, and full efficacy was achieved within the first few days of therapy; these improvements disappeared immediately when treatment was discontinued. Levodopa/benserazide treatment was well tolerated and safe. CONCLUSIONS: Levodopa/benserazide is effective and safe in the treatment of RLS. Objective and subjective measures of sleep improved rapidly after the first dose. RLS symptoms recurred immediately after treatment was discontinued.

Adult↗

High- versus low-lipase acid-resistant enzyme preparations in cystic fibrosis: a crossover randomized clinical trial.

High-strength pancreatic enzyme preparations have recently come into widespread use in some countries for treatment of pancreatic insufficiency in cystic fibrosis. However, the therapeutic equivalence of these preparations to the standard acid-resistant microsphere preparations, under the same lipase dosage, has not been demonstrated by appropriate clinical trials; they are also considered responsible for severe colonic stricture. In a randomized crossover study, 20 adolescent or adult cystic fibrosis patients were treated in hospital with both low-lipase (A) and high-lipase (B) enteric-coated microsphere preparations. The fat excretion coefficient, evaluated over two 72-h fat balance periods (measured fat intake, 1.43 to 3 g/kg/day according to age), was the main response variable, secondary variables being stool wet and dry weight, fecal nitrogen output, and energy loss. With both preparations, patients were given a daily dose of 1,500-2,000 lipase BP U/g fat ingested, distributed across four meals. The low-strength preparation was divided into three doses during each meal, while the high-strength preparation was taken as a single dose in the middle of each meal. The considerable variability of results did not provide conclusive evidence of equivalence or significant differences between the two preparations in terms of steatorrhea and other variables. However, mean differences between the two treatments and their 95% confidence intervals showed less satisfactory results with the high-lipase preparation. A high-strength preparation is thought to release relatively less enzyme activity in the small intestine, forcing patients to increase their dosage and possibly creating a dangerous enzyme hyperconcentration in the large intestine. For this reason, the occasional occurrence of colonic stricture should be borne in mind, as must the possible scope for division of dosage during each meal.

Adolescent↗

Predicting response to rhDNase and hypertonic saline in children with cystic fibrosis.

Daily recombinant human deoxyribonuclease (rhDNase) is an established but expensive treatment in cystic fibrosis (CF). Alternate-day rhDNase and hypertonic saline (HS) represent potential cheaper alternative therapies. However, not all patients improve on treatment. To assess response, many CF centers have developed formal n-of-1 trials of treatment to find out who benefits. Response to daily rhDNase at 3 months has been shown to be a good predictor of response at 1 year. There are no data correlating individual response at a shorter time period with 3-month response. We assessed whether individual responses to daily rhDNase, alternate-day rhDNase, and HS could be predicted from lung function response at 6 weeks, thus shortening the n-of-1 trial, or from baseline patient characteristics, therefore avoiding the need for an n-of-1 trial. In a randomized crossover trial, 48 CF children were allocated consecutively to 12 weeks of once-daily 2.5-mg rhDNase, alternate-day 2.5-mg rhDNase, and twice-daily 5 ml of 7% HS. Forced expiratory volume in 1 sec (FEV1) and forced vital capacity (FVC) were measured at baseline and then at 6 and 12 weeks into each treatment period. Lung function response to the drugs at 6 weeks was highly predictive of response at 3 months. There was some evidence that response to HS was worse in patients with lower baseline lung function. However, there was no association between response to alternate-day or daily rhDNase and baseline characteristics. In conclusion, response to rhDNase and HS at 6 weeks was highly predictive of response at 3 months. For daily and alternate-day rhDNase, at least, the drug needs to be administered for at most 6 weeks initially to assess long-term response to treatment. Response to treatment could not be reliably predicted from baseline characteristics.

Adolescent↗

Breathing during sleep in menopause: a randomized, controlled, crossover trial with estrogen therapy.

OBJECTIVE: To evaluate the prevalence of different types of nocturnal breathing abnormalities in postmenopausal women and the effect of estrogen replacement therapy (ERT) on nocturnal breathing. METHODS: A prospective, randomized, placebo-controlled, double-blind, crossover study was completed by 62 of 71 recruited healthy women. The first 3-month treatment period with either estrogen or placebo was followed by placebo washout for a month and then by a second treatment period with crossover to either estrogen or placebo. On a night after each treatment period, sleep was monitored with polysomnography, and breathing was assessed with a static-charge-sensitive bed and oximeter. For the respiratory variables, a sample size of 48 subjects was sufficient to give statistical power of 85% with a significance level of P <.05. RESULTS: The occurrence of obstructive sleep apnea in all women was low (1.6%), but partial upper airway obstruction, manifesting as an increased respiratory resistance pattern, was more common (17.7%). Estrogen replacement therapy decreased the occurrence (P =.047) and frequency (P =.049) of sleep apnea but had no effect on partial upper airway obstruction or arterial oxyhemoglobin saturation. CONCLUSION: Partial upper airway obstruction is the most prevalent form of sleep-disordered breathing, occurring ten times more frequently than sleep apnea in postmenopausal women. Unopposed estrogen replacement therapy has only a minor effect on sleep apnea and has no effect on partial airway obstruction.

Cross-Over Studies↗

Diurnal differences in the effects of heat exposure on renal function: A randomized controlled crossover trial.

High temperature is a major risk factor for kidney injury, and population exposure to nighttime heat is increasing as the climate warms. However, whether renal responses to heat exposure differ between daytime and nighttime remains unclear. Forty-one healthy adults participated in a randomized crossover experiment conducted in a controlled laboratory setting. Participants were exposed to heat (32&#xb0;C during daytime; 30&#xb0;C during nighttime) and thermoneutral conditions (26&#xb0;C) for 8&#x202f;h. Blood and urine samples were collected before and after each exposure to examine various renal biomarkers reflecting glomerular filtration function, tubular injury, and early kidney stress. Heat exposure affected both blood and urinary biomarkers of kidney function, with notable diurnal differences in renal responses. Daytime heat exposure primarily affected blood markers of glomerular filtration, increasing creatinine by 7.67% (95% CI: 4.73%-10.61%) and cystatin C by 3.05% (95% CI: 0.17%-5.93%), while reducing estimated glomerular filtration rate by 0.05% (95% CI: 0.02%-0.08%). In contrast, nighttime heat exposure predominantly elevated urinary biomarkers of early kidney stress, including insulin-like growth factor-binding protein 7 (58.40%, 95% CI: 27.66%-89.14%), kidney injury molecule-1 (47.25%, 95% CI: 18.91%-75.59%), and tissue inhibitor of metalloproteinases-2 (51.88%, 95% CI: 22.26%-81.51%). Moreover, increases in insulin-like growth factor-binding protein 7 were significantly greater at night than during the day. Sleep-related parameters, including sleep quality, duration, and heart rate variability, partially mediated nighttime heat effects on renal responses. These results indicated that heat exposure induced different diurnal patterns in renal responses.

Humans↗

A randomized crossover efficacy trial of oral CPAP (Oracle) compared with nasal CPAP in the management of obstructive sleep apnea.

STUDY OBJECTIVES: To determine the therapeutic efficacy and viability of a novel oral interface for continuous positive airway pressure (CPAP) compared with conventional nasal interfaces. DESIGN: A randomized single-blind crossover study. SETTING: Hospital-based sleep laboratory. PATIENTS OR PARTICIPANTS: 21 CPAP-naïve patients with obstructive sleep apnea (baseline apnea-hypopnea index, 85 +/- 36) INTERVENTIONS: Nasal CPAP and oral CPAP MEASUREMENTS AND RESULTS: Patients were each treated for two 4-week periods using nasal CPAP and oral CPAP. The CPAP titrations were undertaken at the start of each treatment arm. Outcome measures were recorded at baseline and at the end of each treatment arm. These included polysomnography variables, CPAP compliance, subjective sleepiness, obstructive sleep apnea symptom ratings, and adverse effects. There were no significant differences between oral and nasal interfaces for the on-CPAP frequency of apneas and hypopneas (mean difference, nasal-oral [95%CI] = -4.6[-10.1-1.0]/h; P = 0.06) or arousals (-3.0 [-7.8-1.8]/h; P = 0.23). There were also no statistically significant differences between interfaces for scores on the Epworth Sleepiness Scale (-0.7 [-3.1-1.7]; P = 0.20), obstructive sleep apnea symptoms (-7.7 [-17.7-2.4]; P = 0.052), CPAP compliance (0.3 [-0.5-1.1] h/night; P = 0.50), CPAP pressure (0.05 [-0.66-0.76] cmH20; P = 0.73), CPAP side effects scores (-2.0 [-5.3-1.4]; P = 0.23), or mask preference (P = 0.407). In addition, both nasal and oral interfaces significantly improved polysomnographic variables, Epworth Sleepiness Scale scores, obstructive sleep apnea symptoms, and CPAP compliance from baseline (all P < 0.05). CONCLUSIONS: This preliminary study indicates that oral CPAP has similar efficacy to traditionally applied nasal CPAP in treating obstructive sleep apnea. Additional large studies are required to determine the range of clinical situations where oral CPAP is indicated.

Administration, Oral↗

Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens in children with type 1 diabetes: a randomized open crossover trial.

OBJECTIVE: To compare the efficacy and feasibility of continuous subcutaneous insulin infusion (CSII) with multiple daily insulin injections (MDI) in children with type 1 diabetes. METHODS: The study sample included 23 children (10 males) aged 9.4 to 13.9 years with type 1 diabetes. An open randomized crossover design was used to compare 3.5 months of CSII to 3.5 months of MDI therapy for the following variables: diabetic control, incidence of adverse events, daily insulin requirement, body mass index standard deviation scores, treatment satisfaction, and quality of life. RESULTS: The changes in HbA(1c) and fructoseamine values were similar in the 2 arms over time. At the end of the study, mean HbA(1c) level measured 8.05 +/- 0.78%. There were no differences between the treatment modes in frequency of symptomatic hypoglycemic or hyperglycemic events. There was 1 event of severe hypoglycemia during pump therapy and 3 during MDI, yielding a rate of 0.26 events per patient-year. There were no episodes of diabetic ketoacidosis. Body mass index standard deviation scores decreased during CSII and increased during MDI, as did mean insulin dose. Patients expressed a higher treatment satisfaction from CSII than MDI, although there was no difference in quality of life between the 2 modes. CONCLUSIONS: Intensive insulin therapy by either insulin pump or MDI is safe in children and young adolescents with type 1 diabetes, with similar diabetes control and a very low rate of adverse events. We suggest that both modes be available to the diabetic team to better tailor therapy.

Adolescent↗

Web-based learning versus standardized patients for teaching clinical diagnosis: a randomized, controlled, crossover trial.

BACKGROUND: Little evidence exists to guide the selection of methods for teaching clinical diagnosis. PURPOSE: To compare the efficacy, student preference, and cost of a Web-based (WB) program versus a standardized patient (SP) encounter for teaching clinical diagnosis skills to 2nd-year medical students. METHODS: Randomized, controlled, crossover study comparing WB versus SP-based teaching for the clinical diagnosis of abdominal pain and headache. Outcome measures were performance on a 2-case SP examination (scored on the basis of a checklist completed by a faculty observer and an objective score on a postencounter subjective-objective assessment plan [SOAP] note), format preferences as assessed by end-of-course evaluations, and cost. RESULTS: Thirty students consented to participate. WB and SP training produced similar scores on both the Abdominal Pain checklist (66% vs. 62%; p = .17) and Headache checklist (56% vs. 63%; p = .07). WB training produced a higher score on the Abdominal Pain SOAP note (69% vs. 47%; p = .006), but not the Headache SOAP note (69% vs. 67%; p = .85). Students rated the SP format higher than the WB format on all 7 preference measures. Start-up costs were estimated at 2,190 dollars for the SP format and 2,250 dollars for the WB format. Ongoing costs per case per student were estimated to be 45 dollars for the SP format and 30 dollars for the WB format. CONCLUSIONS: WB and SP learning outcomes were comparable, but students preferred the SP format. Start-up costs were comparable, but the ongoing costs of the WB format were less expensive, suggesting that WB teaching may be a viable strategy.

Algorithms↗

Dual-chamber pacing for hypertrophic cardiomyopathy: a randomized, double-blind, crossover trial.

OBJECTIVES: In a double-blind, randomized, crossover trial we sought to evaluate the effect of dual-chamber pacing in patients with severe symptoms of hypertrophic obstructive cardiomyopathy. BACKGROUND: Recently, several cohort trials showed that implantation of a dual-chamber pacemaker in patients with severely symptomatic hypertrophic obstructive cardiomyopathy can relieve symptoms and decrease the severity of the left ventricular outflow tract gradient. However, the outcome of dual-chamber pacing has not been compared with that of standard therapy in a randomized, double-blind trial. METHODS: Twenty-one patients with severely symptomatic hypertrophic obstructive cardiomyopathy were entered into this trial after baseline studies consisting of Minnesota quality-of-life assessment, two-dimensional and Doppler echocardiography and cardiopulmonary exercise tests. Nineteen patients completed the protocol and underwent double-blind randomization to either DDD pacing for 3 months followed by backup AAI pacing for 3 months, or the same study arms in reverse order. RESULTS: Left ventricular outflow tract gradient decreased significantly to 55 +/- 38 mm Hg after DDD pacing compared with the baseline gradient of 76 +/- 61 mm Hg (p < 0.05) and the gradient of 83 +/- 59 mm Hg after AAI pacing (p < 0.05). Quality-of-life score and exercise duration were significantly improved from the baseline state after the DDD arm but were not significantly different between the DDD arm and the backup AAI arm. Peak oxygen consumption did not significantly differ among the three periods. Overall, 63% of patients had symptomatic improvement during the DDD arm, but 42% also had symptomatic improvement during the AAI backup arm. In addition, 31% had no change and 5% had deterioration of symptoms during the DDD pacing arm. CONCLUSIONS: Dual-chamber pacing may relieve symptoms and decrease gradient in patients with hypertrophic obstructive cardiomyopathy. In some patients, however, symptoms do not change or even become worse with dual-chamber pacing. Subjective symptomatic improvement can also occur from implantation of the pacemaker without its hemodynamic benefit, suggesting the role of a placebo effect. Long-term follow-up of a large number of patients in randomized trials is necessary before dual-chamber pacing can be recommended for all patients with severely symptomatic hypertrophic obstructive cardiomyopathy.

Adult↗

Improved sleep continuity and increased slow wave sleep and REM latency during ziprasidone treatment: a randomized, controlled, crossover trial of 12 healthy male subjects.

OBJECTIVE: Ziprasidone, an atypical antipsychotic, is a potent dopamine (D(2)) and serotonin (5-HT(2A/C)) receptor blocker, has agonistic properties at the 5-HT(1A) receptor, and blocks serotonin and norepinephrine reuptake. These transmitter systems are closely related to the regulation of sleep. METHOD: The aim of this double-blind, placebo-controlled, randomized, crossover study was to investigate the effects of ziprasidone on polysomnographic sleep structure and subjective sleep quality. Twelve healthy male subjects were randomly assigned to receive ziprasidone 40 mg or placebo for 2 sessions each composed of 2 consecutive nights (night 1, standard sleep conditions; night 2, acoustic stress) 5 days apart. Treatment was administered orally 2 hours before bedtime. The study was conducted from April 2004 to July 2004. RESULTS: Ziprasidone significantly increased total sleep time, sleep efficiency, percentage of sleep stage 2, and slow wave sleep; decreased the number of awakenings; and significantly affected tonic and phasic REM sleep parameters, i.e., it decreased percentage of REM and REM density and profoundly increased REM latency. CONCLUSION: Ziprasidone's effects on the sleep profile are somehow opposite to what is known about sleep of depressed patients (e.g., disturbances of sleep continuity, a reduciton of slow wave sleep, and a disinhibition of REM sleep). Its REM sleep-suppressing properties resemble those of most, although not all, antidepressants and may be clinically relevant. The drug also demonstrates sleep-consolidating properties under both standard routine and acoustic stress conditions. These effects are most likely related to ziprasidone's 5-HT(2C) antagonism, 5-HT(1A) agonism, and serotonin and norepinephrine reuptake inhibition.

Acoustic Stimulation↗

A randomized prospective crossover trial of amlodipine in pediatric hypertension.

Amlodipine has potential advantages in children since it can be dissolved into a liquid preparation and has a long elimination half-life, allowing for once-daily administration. The objective of this study was to compare the efficacy and compliance of amlodipine with that of standard long-acting calcium channel blockers (felodipine or nifedipine) in hypertensive children. A randomized, prospective, crossover study of 11 hypertensive children (9-17 years of age, 10 renal transplant patients) was performed with electronic monitoring of compliance. Each treatment arm was 30 days. No significant differences were observed in mean systolic (SBP) and diastolic blood pressures (DBP) between amlodipine and the other calcium channel blockers. Using 24-h blood pressure monitoring there were no significant differences over each drug treatment period in both mean day-time and night-time SBP and DBP. Patient compliance was similar in both the amlodipine and the nifedipine/felodipine treatment periods. These data suggest that amlodipine is as effective in pediatric nephrology patients as nifedipine and felodipine. Amlodipine may be optimally suited for treatment of young children because at present it is the only calcium channel blocker which can be administered once daily as a liquid preparation.

Adolescent↗

Platelet transfusions in children: results of a randomized, prospective, crossover trial of plasma removal and a prospective audit of WBC reduction.

BACKGROUND: Febrile nonhemolytic transfusion reactions (FNHTRs) complicate 2 to 37 percent of platelet transfusions in adults, but the incidence of such reactions in children is not known. The effectiveness of plasma reduction after storage and WBC reduction of platelet concentrates before storage was studied in pediatric recipients of platelet transfusions. STUDY DESIGN AND METHODS: In the first study, a prospective randomized crossover design was used in which patients received either unmodified whole-blood-derived or apheresis platelets or platelets from which most of the plasma supernatant had been removed just before transfusion. The second study was a prospective audit of recipients of prestorage WBC-reduced platelets. Children between 3 months and 17 years of age were eligible for both studies. Patients were assessed for signs and symptoms that are characteristic of a reaction during, immediately after, and 2 hours following transfusion. RESULTS: There were 226 platelet transfusions administered to 66 children. One hundred and sixty transfusions were given to 35 children enrolled in the randomized study, and 66 transfusions were given to 33 children during the audit. In the randomized study, nine of the 75 transfusions of unmodified platelets (12%) and six of 85 transfusions of poststorage plasma-removed platelets (7%) were associated with an FNHTR (p=0.42). In the audit, three of 66 transfusions of prestorage WBC-reduced platelets (5%) were associated with an FNHTR. Allergic reactions occurred with 5 percent (4 of 75), 6 percent (5 of 85), and 6 percent (4 of 66) of platelet transfusions, respectively. CONCLUSION: FNHTRs appear to be less common among pediatric recipients of platelet transfusions than in adults. In our two studies, there was a trend toward a lower frequency of FNHTRs with poststorage plasma removal and prestorage WBC reduction than with standard platelets, but this was not significant.

Adolescent↗