SEARCH · PubMed Health

Results for “randomized crossover trial”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 145 records · Page 8Linked to original sources

PubMed2001

Comparison of the soluble basal insulin analog insulin detemir with NPH insulin: a randomized open crossover trial in type 1 diabetic subjects on basal-bolus therapy.

OBJECTIVE: Insulin detemir (NN304) is a soluble basal insulin analog developed to cover basal insulin requirements. This trial aimed to compare the blood glucose-lowering effect of insulin detemir with that of NPH insulin (NPH) and to evaluate the two treatments with regard to intrasubject variation of fasting blood glucose, incidence of hypoglycemia, dose requirements, and safety. RESEARCH DESIGN AND METHODS: This multicenter open randomized crossover trial in 59 type 1 diabetic subjects comprised a 2-week run-in period on a basal-bolus regimen with NPH insulin once daily, followed by two 6-week periods of optimized basal-bolus therapy with either once-daily insulin detemir or NPH insulin. RESULTS: The area under the curve, in the time interval 23:00-8:00, derived from 24-h serum glucose profiles, was not statistically significantly different for the two treatment periods (insulin detemir:NPH ratio 89.2:83.5, P = 0.59). The intrasubject variation in fasting blood glucose during the last 4 days of treatment was lower for insulin detemir compared with NPH (P < 0.001). Mean dose requirements of insulin detemir were 2.35 times higher (95% CI 2.22-2.48) compared with NPH. During the last week of treatment, fewer subjects experienced hypoglycemic episodes on insulin detemir (60%) compared with NPH treatment (77%) (P = 0.049). CONCLUSIONS: Insulin detemir was as effective as NPH in maintaining glycemic control when administered at a higher molar dose. The results indicate that insulin detemir may provide more predictable fasting blood glucose with lower intrasubject variation and reduced risk of hypoglycemia compared with NPH.

Adolescent↗

PubMed2004

A randomized, placebo-controlled, crossover clinical trial of super blue-green algae in patients with essential blepharospasm or Meige syndrome.

PURPOSE: To evaluate the effectiveness of super blue-green algae (SBGA) supplements on the severity of essential blepharospasm treated with botulinum toxin A injections. DESIGN: Double-masked, placebo-controlled, two-period, crossover randomized trial. PATIENTS AND METHODS: The study was carried out in patients with essential blepharospasm or Meige syndrome undergoing routine treatment with botulinum toxin A injections. INTERVENTION: Patients were randomly assigned to either SBGA capsules or placebo. After 6 months of treatment, patients underwent a 6-month washout period with no treatment, then were administered the alternate treatment for an additional 6 months, thus serving as their own controls. MAIN OUTCOME MEASURES: Video documentation of blink rate and involuntary facial movements, time between botulinum toxin A injections, and patients' subjective assessment of the impact of blepharospasm on functioning were obtained at the beginning and end of the first and second (crossover) treatment periods. RESULTS: A total of 24 patients (10 men, 14 women; aged 42 to 83 years) completed both treatment periods. Mean within-patient difference in blink rate between SBGA and placebo periods was -2.1 blinks per 2 minutes (95% confidence interval [CI]: -20.8-+31.9), not statistically different from zero (P =.83). Mean within-patient difference in time between injections between SBGA and placebo periods was 4.6 days (95% CI: -13.3-+22.5), not statistically different from zero (P =.62). The lack of statistical significance may have been because of small sample size. There were no significant differences in severity of involuntary movement between SBGA and placebo treatment periods. However, patients were more likely to report limitation in function during the period they took SBGA than during the period they took placebo (odds ratio, 0.2; P =.03). CONCLUSION: Overall, we found no evidence of a beneficial effect of SBGA as an adjunct to botulinum toxin A injections; however, a few patients, all younger than 60 years, did appear to benefit from SBGA.

Adult↗

PubMed2004

Exercise training for patients with heart failure: a systematic review of factors that improve mortality and morbidity.

PURPOSE: To determine the efficacy of exercise training and its effects on outcomes in patients with heart failure. METHODS: MEDLINE, Medscape, and the Cochrane Controlled Trials Registry were searched for trials of exercise training in heart failure patients. Data relating to training protocol, exercise capacity, and outcome measures were extracted and reviewed. RESULTS: A total of 81 studies were identified: 30 randomized controlled trials, five nonrandomized controlled trials, nine randomized crossover trials, and 37 longitudinal cohort studies. Exercise training was performed in 2387 patients. The average increment in peak oxygen consumption was 17% in 57 studies that measured oxygen consumption directly, 17% in 40 studies of aerobic training, 9% in three studies that only used strength training, 15% in 13 studies of combined aerobic and strength training, and 16% in the one study on inspiratory training. There were no reports of deaths that were directly related to exercise during more than 60,000 patient-hours of exercise training. During the training and follow-up periods of the randomized controlled trials, there were 56 combined (deaths or adverse events) events in the exercise groups and 75 combined events in the control groups (odds ratio [OR] = 0.98; 95% confidence interval [CI]: 0.61 to 1.32; P = 0.60). During this same period, 26 exercising and 41 nonexercising subjects died (OR = 0.71; 95% CI: 0.37 to 1.02; P = 0.06). CONCLUSION: Exercise training is safe and effective in patients with heart failure. The risk of adverse events may be reduced, but further studies are required to determine whether there is any mortality benefit.

Exercise↗

PubMed2006

Enhanced upper respiratory tract airflow and head fanning reduce brain temperature in brain-injured, mechanically ventilated patients: a randomized, crossover, factorial trial.

BACKGROUND: Heat loss from the upper airways and through the skull are physiological mechanisms of brain cooling which have not been fully explored clinically. METHODS: This randomized, crossover, factorial trial in 12 brain-injured, orally intubated patients investigated the effect of enhanced nasal airflow (high flow unhumidified air with 20 p.p.m. nitric oxide gas) and bilateral head fanning on frontal lobe brain temperature and selective brain cooling. After a 30 min baseline, each patient received the four possible combinations of the interventions--airflow, fanning, both together, no intervention--in randomized order. Each combination was delivered for 30 min and followed by a 30 min washout, the last 5 min of which provided the baseline for the next intervention. RESULTS: The difference in mean brain temperature over the last 5 min of the preceding washout minus the mean over the last 5 min of intervention, was 0.15 degrees C with nasal airflow (P=0.001, 95% CI 0.06-0.23 degrees C) and 0.26 degrees C with head fanning (P<0.001, 95% CI 0.17-0.34 degrees C). The estimate of the combined effect of airflow and fanning on brain temperature was 0.41 degrees C. Selective brain cooling did not occur. CONCLUSION: Physiologically, this study demonstrates that heat loss through the upper airways and through the skull can reduce parenchymal brain temperature in brain-injured humans and the onset of temperature reduction is rapid. Clinically, in ischaemic stroke, a temperature decrease of 0.27 degrees C may reduce the relative risk of poor outcome by 10-20%. Head fanning may have the potential to achieve a temperature decrease of this order.

Adult↗

PubMed2003

The effect of short-term dimethylglycine treatment on oxygen consumption in cytochrome oxidase deficiency: a double-blind randomized crossover clinical trial.

OBJECTIVE: To study the effectiveness of dimethylglycine (DMG) on oxygen consumption (VO(2)) in children with Saguenay-Lac-Saint-Jean cytochrome-c oxidase (SLSJ-COX) deficiency (OMIM 220111). STUDY DESIGN: In a crossover randomized double-blind clinical trial, 5 children with SLSJ-COX deficiency, who were stable and old enough to comply with VO(2) measurement, were treated with placebo or DMG for 3 days, and with the alternate treatment after a 2-week washout period. VO(2) was measured by indirect calorimetry before and after treatment. Dietary caloric intake was calculated for 3 days before each measurement. Mean caloric intakes per day were 1562 and 1342 kcal x m(-2) before and during placebo, 1,336 and 1,380 before and during DMG, respectively. RESULTS: DMG was well tolerated and, in all cases, resulted in markedly increased blood DMG levels (617 + 203 mmol x L(-1)), versus 0 to 2 mmol x L(-1) without treatment. Mean VO(2) was lower after administration of either DMG (-1 +/- 3 mL x min(-1) x m(-2)) or placebo (-6 +/- 4), but neither difference was statistically significant. There was no detectable effect of DMG treatment on blood levels of lactate, pyruvate, bicarbonate, or pH. VO(2) values of patients (range, 101-135 mL x min(-1) x m(-2)) were lower than published norms (150-160 mL x min(-1) x m(-2)). CONCLUSION: This study suggests that treatment with DMG does not substantially change VO(2) in children with SLSJ-COX deficiency.

Child↗

PubMedDate not supplied

Coffee consumption and blood pressure: a randomized, crossover clinical trial.

OBJECTIVE: To examine the effect of moderate coffee consumption on blood pressure over a prolonged period of time. Previous work in this area has used primarily purified caffeine. DESIGN: A prospective, randomized, crossover clinical trial. SETTING: A hypertension specialty outpatient clinic at the University of Tennessee, Memphis. PATIENTS: Healthy, young, white men who were moderate coffee drinkers (less than 6 cups/day) were recruited. Twenty-four subjects were randomized and 21 (average age 35.5 years) completed the trial. INTERVENTIONS: Subjects were randomized to one of two groups: Group A drank three or more cups of coffee/day for two months, then crossed over to abstaining from coffee for two months; group B abstained from coffee first, then crossed over to drinking coffee. Only filter-brewed coffee was used. Subjects were seen at monthly intervals for blood pressure measurements. MEASUREMENTS AND MAIN RESULTS: The average coffee consumption was 3.6 cups/day during the coffee-drinking phases. There was no difference between the coffee-drinking phase and the abstention phase in either systolic blood pressure (110.1 mmHg vs. 108.0 mmHg, respectively; 95% CI of difference -7.3, 2.5) or diastolic blood pressure (67.2 mmHg vs. 69.6 mmHg, respectively; 95% CI of difference -2.2, 6.4). CONCLUSIONS: Moderate daily consumption of coffee does not elevate blood pressure.

Adult↗

PubMed2005

Functional incidental training: a randomized, controlled, crossover trial in Veterans Affairs nursing homes.

OBJECTIVES: To test the effects of a rehabilitative intervention directed at continence, mobility, endurance, and strength (Functional Incidental Training (FIT)) in older patients in Department of Veterans Affairs (VA) nursing homes. DESIGN: Randomized, controlled, crossover trial. SETTING: Four VA nursing homes. PARTICIPANTS: All 528 patients in the nursing homes were screened; 178 were eligible, and 107 were randomized to an immediate intervention group (Group 1; n=52) and a delayed intervention group (Group 2; n=55). INTERVENTION: Trained research staff provided the FIT intervention, which included prompted voiding combined with individualized, functionally oriented endurance and strength-training exercises offered four times per day, 5 days per week, for 8 weeks. Group 1 received the intervention while Group 2 served as a control group; then Group 2 received the intervention while Group 1 crossed over to no intervention. A total of 64 subjects completed the intervention phase of the trial. MEASUREMENTS: Timed measures of walking or wheeling a wheelchair (mobility), sit-to-stand exercises, independence in locomotion and toileting as assessed using the Functional Independence Measure (FIM), one-repetition maximum weight for several measures of upper and lower body strength, frequency of urine and stool incontinence, and appropriate toileting ratios. RESULTS: There was a significant effect of the FIT intervention on virtually all measures of endurance, strength, and urinary incontinence but not on the FIM for locomotion or toileting. The effects of FIT were observed when Group 1 received the intervention and was compared with the control group and when Group 2 crossed over to the intervention. Group 1 deteriorated in all measures during the 8-week crossover period. Within-person comparisons also demonstrated significant effects on all measures in the 64 participants who completed the intervention; 43 (67%) of these participants were "responders" based on maintenance or improvement in at least one measure of endurance, strength, and urinary incontinence. No adverse events related to FIT occurred during the study period. CONCLUSION: FIT improves endurance, strength, and urinary incontinence in older patients residing in VA nursing homes. Translating these positive benefits achieved under research conditions into practice will be challenging because of the implications of the intervention for staff workload and thereby the costs of care.

Activities of Daily Living↗

PubMed1990

Coffee consumption and serum lipids: a randomized, crossover clinical trial.

PURPOSE: The purpose of this study was to determine the effect of consuming three or more cups of filter-brewed coffee per day on levels of serum lipids. SUBJECTS AND METHODS: A prospective, randomized crossover clinical trial was performed. Twenty-one healthy white male subjects completed the trial, and consumed an average of 3.6 cups of coffee a day. Data were evaluated by analysis of variance for repeated measures and t-test for paired means. RESULTS: No effect of coffee consumption on serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, or apolipoprotein B was found. Diet, creamer use, and cigarette use as well as group assignment and time factors were controlled for in the analysis. CONCLUSION: We found no effect of moderate consumption of filter-brewed coffee on serum levels of atherogenic lipids. This study supports previous work that filtered coffee has no adverse effect on serum lipids. This has far-reaching implications given the widespread use of coffee and the current concern over coronary risk factors.

Adult↗

PubMed2006

Impact of self-assessment questions and learning styles in Web-based learning: a randomized, controlled, crossover trial.

PURPOSE: To determine the effect of self-assessment questions on learners' knowledge and format preference in a Web-based course, and investigate associations between learning styles and outcomes. METHOD: The authors conducted a randomized, controlled, crossover trial in the continuity clinics of the Mayo-Rochester internal medicine residency program during the 2003-04 academic year. Case-based self-assessment questions were added to Web-based modules covering topics in ambulatory internal medicine. Participants completed two modules with questions and two modules without questions, with sequence randomly assigned. Outcomes included knowledge assessed after each module, format preference, and learning style assessed using the Index of Learning Styles. RESULTS: A total of 121 of 146 residents (83%) consented. Residents had higher test scores when using the question format (mean +/- standard error, 78.9% +/- 1.0) than when using the standard format (76.2% +/- 1.0, p = .006). Residents preferring the question format scored higher (79.7% +/- 1.1) than those preferring standard (69.5% +/- 2.3, p < .001). Learning styles did not affect scores except that visual-verbal "intermediate" learners (80.6% +/- 1.4) and visual learners (77.5% +/- 1.3) did better than verbal learners (70.9% +/- 3.0, p = .003 and p = .033, respectively). Sixty-five of 78 residents (83.3%, 95% CI 73.2-90.8%) preferred the question format. Learning styles were not associated with preference (p > .384). Although the question format took longer than the standard format (60.4 +/- 3.6 versus 44.3 +/- 3.3 minutes, p < .001), 55 of 77 residents (71.4%, 60.0-81.2%) reported that it was more efficient. CONCLUSIONS: Instructional methods that actively engage learners improve learning outcomes. These findings hold implications for both Web-based learning and "traditional" educational activities. Future research, in both Web-based learning and other teaching modalities, should focus on further defining the effectiveness of selected instructional methods in specific learning contexts.

Cross-Over Studies↗

PubMed1991

Randomized, controlled, crossover trial of oat bran in hypercholesterolemic subjects.

BACKGROUND: Despite animal and metabolic ward studies that support the benefit of oat bran as a useful dietary supplement for the lowering of cholesterol, there have been few controlled studies on free-living subjects that have convincingly demonstrated this benefit. METHODS: This is a report of a randomized, controlled, blinded clinical trial with a crossover design using oat bran (28 g [1 oz] twice daily) vs wheat cereal as a supplement to a fat-modified diet for the reduction of total cholesterol and low-density lipoprotein (LDL) cholesterol. The study included male and female subjects aged 20 to 70 years, with baseline LDL cholesterol in the 50th to 95th percentile. All subjects were instructed in the American Heart Association Step I (AHA-I) diet, and eating behavior was monitored using 4-day food records during each study period. RESULTS: Eighty-two percent (n = 145) of the total number of subjects who were randomized to treatment groups completed the study. Blood lipid studies demonstrated significantly greater reductions in total cholesterol (average -2.2%) and LDL cholesterol (average -3.9%) in the oat-bran groups than in the wheat-cereal groups (average total cholesterol +3.3%, average LDL cholesterol +4.0%) or in the diet alone group (total cholesterol +6.0%; LDL cholesterol +6.4%). All groups did comparably well at adhering to the AHA-I diet; however, dietary factors alone, when analyzed by the Keys equations, could not explain the group differences in lipid change. CONCLUSIONS: The addition of oat bran (28 g [1 oz] twice daily) to the AHA-I diet provided significant added benefit in lowering total cholesterol and LDL cholesterol in most hypercholesterolemic subjects. Analysis for factors that predict LDL cholesterol response to oat bran revealed a significant age-by-sex interaction (P less than .001). Women under the age of 50 years, as a group, showed essentially no increased benefit from the addition of oat bran to their diet. Cholesterol levels in older women appear to be significantly more responsive to a modified diet containing oat bran than those of younger women.

Adult↗

PubMedDate not supplied

The management of rhinitis in patients with functional epiphora: a randomized controlled crossover trial.

BACKGROUND: Nasolacrimal duct obstruction, secondary to inflammation of the nasal mucosa, can result in epiphora. This can be treated successfully with topical corticosteroids, avoiding the need for surgery. This study tests the hypothesis that treating clinically significant rhinitis improves the symptoms of epiphora. METHODS: A randomized controlled crossover trial (pilot study) was performed at the Cumberland Infirmary, Carlisle. Patients were assessed in an epiphora clinic by a consultant ophthalmologist and were included in the trial if they had bilateral functional epiphora, i.e., the nasolacrimal duct was patent on syringing. Twenty-three patients were then referred to a consultant otolaryngologist, where the severity of rhinitis and epiphora were assessed using visual analogue scales, subjective scoring, and clinical assessment. The 11 patients suitable for the study were randomized into two groups. The treatment group received nasal corticosteroids and the control group received no treatment, both groups changing treatment arms at a specified point. Subjective and objective scores were assessed at the beginning, midpoint, and end of each treatment period. RESULTS: Seven of 11 patients showed an improvement in epiphora scores with topical therapy. Six patients documented a symptomatic improvement. Eight patients showed an improvement in symptoms and signs of rhinitis, with two patients continuing on nasal corticosteroids for nasal symptoms only. There was a statistically significant improvement in both epiphora symptom scores and clinical findings of rhinitis in patients treated with nasal steroids (p = 0.021 and 0.019, respectively). CONCLUSION: Epiphora secondary to rhinitis can be treated successfully with intranasal steroids. Patients with epiphora should be asked about symptoms of rhinitis and should always have their nose examined for evidence of intranasal pathology.

Aged↗

PubMed2003

A double-blind, randomized, incomplete crossover trial to assess the dose proportionality of rosuvastatin in healthy volunteers.

BACKGROUND: Rosuvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, has been developed for the treatment of patients with dyslipidemia. OBJECTIVE: This study assessed the dose proportionality and pharmacokinetics of single oral doses of rosuvastatin in healthy volunteers. METHODS: This was a double-blind, randomized, incomplete crossover trial consisting of 3 trial days separated by >/=7-day washout periods. Healthy men were allocated to 1 of 2 treatment regimens: rosuvastatin 10, 20, and 80 mg, or rosuvastatin 10, 40, and 80 mg, administered as single doses on separate trial days in random order. Pharmacokinetic and tolerability assessments were made up to 96 hours after administration. Dose proportionality was tested using the power-law approach. RESULTS: Eighteen healthy white men participated in the trial (mean age, 41.2 years; mean height, 178.4 cm; mean body weight, 81.6 kg). Geometric mean rosuvastatin maximum plasma concentration (C(max)) values of 3.75, 6.79, 10.3, and 30.1 ng/mL were achieved at a median time to C(max) of 5.0 hours after doses of 10, 20, 40, and 80 mg, respectively. The corresponding geometric mean values for rosuvastatin area under the plasma concentration-time curve from time 0 to time of the last measurable concentration (AUC(0-t)) were 31.6, 56.8, 98.2, and 268 ng.h/mL. C(max) and AUC(0-t) were both linearly related to dose. The estimates of the proportionality coefficient (90% CI) for CmaX and AUC(o-t) were 0.999 (0.898-1.099) and 1.024 (0.941-1.107), respectively; all values fell within the prespecified range of 0.847 to 1.153. Rosuvastatin was well tolerated in this group of healthy men when administered orally at doses of 10 to 80 mg. CONCLUSION: Rosuvastatin systemic exposure was dose proportional over the dose range of 10 to 80 mg.

Administration, Oral↗

PubMed2005

Egg consumption and endothelial function: a randomized controlled crossover trial.

BACKGROUND: Because of egg cholesterol content, reduction in egg consumption is generally recommended to reduce risk of cardiovascular disease. Recently, however, evidence has been accumulating to suggest that dietary cholesterol is less relevant to cardiovascular risk than dietary saturated fat. This randomized controlled crossover trial was conducted to determine the effects of egg ingestion on endothelial function, a reliable index of cardiovascular risk. METHODS: Forty-nine healthy adults (mean age 56 years, 40% females) underwent a baseline brachial artery reactivity study (BARS), and were assigned to two eggs or oats daily for 6 weeks in random sequence with a 4-week washout. A BARS was done at the end of each treatment phase, measuring flow-mediated vasodilation (FMD) in the brachial artery using a high-frequency ultrasound. RESULTS: FMD was stable in both egg and oat groups, and between-treatment differences were not significant (egg -0.96%, oatmeal -0.79%; p value >0.05). Six weeks of egg ingestion had no effect on total cholesterol (baseline: 203.8 mg/dl; post-treatment: 205.3) or LDL (baseline: 124.8 mg/dl; post-treatment: 129.1). In contrast, 6 weeks of oats lowered total cholesterol (to 194 mg/dl; p = 0.0017) and LDL (to 116.6 mg/dl; p = 0.012). There were no differences in body mass index (BMI), triglyceride, HDL or SBP levels between egg and oat treatment assignments. CONCLUSION: Short-term egg consumption does not adversely affect endothelial function in healthy adults, supporting the view that dietary cholesterol may be less detrimental to cardiovascular health than previously thought.

Cross-Over Studies↗

PubMed2006

Position changes improve visibility during colonoscope withdrawal: a randomized, blinded, crossover trial.

BACKGROUND: Adequate distension is essential to maximize neoplasia detection during colonoscope withdrawal. Position changes may improve distension but are often not performed in routine practice. OBJECTIVE: To assess whether routine position changes improve luminal distension during colonoscope withdrawal. DESIGN: Randomized, blinded, crossover trial. SETTING: Single tertiary-referral center, United Kingdom. PATIENTS: Fourteen patients attending for routine colonoscopy. INTERVENTIONS: Videotaped, back-to-back examination of colon proximal to rectosigmoid junction in left lateral position only, then with position changes: left lateral for the cecum to the hepatic flexure, supine for the transverse colon, and right lateral for the splenic flexure and the descending colon, or vice versa. MAIN OUTCOME MEASUREMENTS: Luminal distension as scored by a blinded video reviewer. Luminal distension was scored on a scale of 1 to 5 for each colonic area: 1, complete collapse; 5, widely distended to limit of view. A score of 2 or less was considered inadequate for diagnosis. RESULTS: Scores for the 2 examinations from the blinded video reviewer were significantly higher in the transverse, the splenic flexure, and the descending colon, P = .02, .002, and <.001, respectively. Without position changes, 6 of 14 of patients (43%) would have had a nondiagnostic distension score (1 or 2) in at least 1 colonic area, P = .03. LIMITATIONS: Nonvalidated scoring system for luminal distension, however, good agreement between endoscopist and blinded reviewer, weighted kappa 0.53, 95% confidence interval 0.38-0.69. CONCLUSIONS: Position change, a cost-neutral intervention, during colonoscope withdrawal improved luminal distension between hepatic flexure and sigmoid-descending junction and has the potential to reduce adenoma and early cancer miss rates.

Colon↗

PubMed2003

A randomized, controlled, crossover trial of oral midazolam and hydroxyzine for pediatric dental sedation.

The effectiveness of oral midazolam in pediatric dentistry is controversial. This randomized, controlled, crossover, double blind clinical trial was conducted in order to study the effect of midazolam, used either alone or in association with hydroxyzine, during child dental treatment. Thirty seven dental sedation sessions were carried out on 11 ASA I uncooperative children less than five years-old. In each appointment children were randomly assigned to groups: P - placebo, M - midazolam (1.0 mg/kg), or MH - midazolam (0.75 mg/kg) plus hydroxyzine (2.0 mg/kg). Vital signs (blood pressure, breathing rate, pulse and oxygen saturation) and behavior parameters (consciousness, crying, movement, overall behavior) were evaluated every 15 minutes. Friedman and Wilcoxon statistical tests were used to compare groups and different moments in the same group. Normal values of vital signs were usually registered. Heart rate increased in groups P and M as the session went on. Group M presented less crying and movement at the first 15 minutes of treatment. Group MH caused more drowsiness at the beginning of the session. Overall behavior was better in group M than in groups P or MH. Group M produced effective sedation in 77% of the cases, and group MH did so in 30.8%. It was concluded that midazolam was effective and safe, and its association with hydroxyzine did not lead to additional advantages in pediatric dental sedation.

Administration, Oral↗

PubMed2003

Heliox does not affect gas exchange during high-frequency oscillatory ventilation if tidal volume is held constant.

OBJECTIVE: To compare gas exchange with heliox and oxygen-enriched air during high-frequency oscillatory ventilation, while controlling for tidal volume, in a pediatric swine model of acute lung injury. We hypothesized that when tidal volume delivery is held constant, heliox does not alter gas exchange. DESIGN: Randomized, crossover trial. SETTING: University animal research laboratory. SUBJECTS: Ten swine (4.4-5.4 kg). INTERVENTIONS: Acute lung injury (A-a gradient of >300 mm Hg) was created using repeated saline lavage during conventional mechanical ventilation. The animals were then administered high-frequency oscillatory ventilation and ventilated with 60% oxygen/40% helium and 60% oxygen/40% nitrogen in a randomized, crossover trial. When changing gas mixtures within each animal, mean airway pressure (Paw = 16.8 +/- 0.3 cm H(2)O) and frequency (10 Hz) were held constant. Oscillation amplitude (DeltaP) was adjusted to maintain constant tidal volume delivery as measured by respiratory inductive plethysmography. Next, the animals were ventilated with 40% oxygen/60% helium and 40% oxygen/60% nitrogen in a randomized crossover trial, again controlling for tidal volume. MEASUREMENTS AND MAIN RESULTS: Gas exchange was assessed by arterial blood gas analysis after ventilation with each gas mixture. We demonstrated no significant difference in Paco(2) or Pao(2) between the heliox and oxygen-enriched air with either the 40% or 60% oxygen mixtures. The oscillation amplitude required to achieve the same tidal volume delivery was significantly less with heliox. CONCLUSIONS: We conclude that if tidal volume delivery is maintained constant, heliox does not alter gas exchange when compared with oxygen-enriched air. However, to achieve the same tidal volume delivery, a lower oscillation amplitude is required with heliox. The clinical benefit of heliox administration during high-frequency oscillatory ventilation has yet to be determined. Possible advantages of heliox include improved ventilation of larger patients when approaching the power limitations of the Sensormedics 3100A oscillator and a potential reduction in the oscillation amplitude delivered to the more proximal gas exchange units.

Animals↗

PubMed2005

A randomized, controlled crossover trial of ondansetron in patients with primary biliary cirrhosis and fatigue.

Fatigue is common in primary biliary cirrhosis (PBC). Altered central serotonergic neurotransmission may be involved in its pathogenesis. This multicenter, randomized, double-blind, placebo-controlled, crossover trial evaluated the efficacy of ondansetron, a selective 5-HT3 receptor subtype antagonist, for treating fatigue in PBC. A crossover design was chosen, allowing subjects to serve as their own controls-appropriate to evaluate fatigue, a subjective symptom. Sixty patients with clinically stable PBC, a Fatigue Severity Score (FSS) > 4, and no other identifiable cause for fatigue were enrolled. Subjects were randomized to receive ondansetron (4 mg) or placebo orally 3 times daily for 4 weeks (period 1). Subjects then crossed over, after a minimum 1-week washout period, for a further 4 weeks of ondansetron or placebo (period 2). Fatigue was measured at the beginning and end of each period by using the FSS and Fatigue Impact Scale (FIS). Six patients withdrew; the remaining 54 subjects had a mean baseline FSS of 5.55 (+/-0.1). Response to study medication in period 1 versus period 2 was not uniform; thus, it was necessary to analyze the trial periods separately. In period 1, there was no significant additional fatigue reduction on ondansetron over placebo. During period 2, FSS and FIS decreased significantly on ondansetron versus placebo (P = .001). However, period 2 results were invalidated because drug side effects unblinded subjects (constipation affected 63.0% of patients taking ondansetron, versus 13.3% on placebo). In conclusion, ondansetron administration did not confer clinically significant fatigue reduction when compared with placebo in our study population.

Constipation↗

PubMed2005

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↗