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1.  Evaluation of the efficacy and safety of olanzapine as an adjunctive treatment for anorexia nervosa in adolescent females: a randomized, double-blind, placebo-controlled trial 
BMC Pediatrics  2008;8:4.
Background
Anorexia Nervosa (AN) is a serious, debilitating condition that causes significant physical, emotional, and functional impairment. The condition is characterized by destructive weight loss behaviours and a refusal to maintain body weight at or above a minimally normal weight for age and height. AN often develops in adolescence and is a predominantly female disorder. Treatment for AN typically involves medical, nutritional and psychological interventions. Pharmacotherapy is also often used; however, the literature on the effectiveness of these drugs in a pediatric population is very limited. Olanzapine, which is an 'atypical' antipsychotic, is becoming more widespread in the treatment of AN. Olanzapine is hypothesized to facilitate weight gain, while decreasing levels of agitation and decreasing resistance to treatment in young women with AN. This randomized, double-blind placebo-controlled trial seeks to examine the effectiveness and safety of olanzapine in female youth with AN.
Methods/Design
Adolescent females between the ages of 12 and 17 diagnosed with AN (either restricting or binge/purge type) or Eating Disorder Not Otherwise Specified with a Body Mass Index of less than or equal to 17.5, will be offered inclusion in the study. Patients will be randomly assigned to receive either olanzapine or placebo. Patients assigned to receive olanzapine will start at a low dose of 1.25 mg/day for three days, followed by 2.5 mg/day for four days, 5 mg/day for one week, then 7.5 mg/day (the target dose chosen) for 10 weeks. After 10 weeks at 7.5 mg the medication will be tapered and discontinued over a period of two weeks. The effectiveness of olanzapine versus placebo will be determined by investigating the change from baseline on measures of eating attitudes and behaviors, depression and anxiety, and change in Body Mass Index at week 12, and after a follow-up period at week 40. It is anticipated that 67 participants will be recruited over two years to complete enrollment.
Discussion
Randomized controlled trials designed to measure the safety and effectiveness of olanzapine in comparison to placebo are desperately needed, particularly in the adolescent population.
Trial registration
Current Controlled Trials ISRCTN23032339
doi:10.1186/1471-2431-8-4
PMCID: PMC2258294  PMID: 18234120
2.  How effective is tetracaine 4% gel, before a venipuncture, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial 
BMC Pediatrics  2007;7:7.
Background
Procedural pain relief is sub-optimal in neonates. Topical tetracaine provides pain relief in children. Evidence of its efficacy and safety in neonates is limited. The objective of this study was to assess the efficacy and safety of topical tetracaine on the pain response of neonates during a venipuncture.
Methods
Medically stable infants greater than or equal to 24 weeks gestation, requiring a venipuncture, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. Participants received oral sucrose if they met local eligibility criteria. The venipuncture was performed according to a standard protocol. A medium effect size in the pain score (corresponding to about 2 point difference in the PIPP score) was considered clinically significant, leading to a sample size of 142 infants, with 80% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test.
Results
One hundred and forty two infants were included, 33 +/- 4 weeks gestation, 2100 +/- 900 grams and 6 +/- 3 days of age. There was almost no difference in PIPP scores at 1 minute between groups (mean difference -0.09; 95% confidence interval [CI]: -1.68 to 1.50; P = . 91). Similarly, there were no differences in PIPP scores during the 2nd, 3rd and 4th minute. Duration of cry did not differ between the groups (median difference, 0; 95% CI, -3 to 0; P = . 84). The majority of infants in both groups received sucrose 24%. Sucrose had a significant effect on the PIPP score, as assessed by an ANOVA model (p = 0.0026). Local skin erythema was observed transiently in 11 infants (7 in the tetracaine and 4 in the placebo group). No serious side effect was observed.
Conclusion
Tetracaine did not significantly decrease procedural pain in infants undergoing a venipuncture, when used in combination with routine sucrose administration.
doi:10.1186/1471-2431-7-7
PMCID: PMC1800845  PMID: 17288611
3.  Effect of point of care information on inpatient management of bronchiolitis 
BMC Pediatrics  2007;7:4.
Background
We studied the effects of access to point-of-care medical evidence in a computerised physician order entry system (CPOE) on management and clinical outcome of children with bronchiolitis.
Methods
This was a before-after study that took place in a Canadian tertiary care paediatric teaching hospital. The intervention was a clinical evidence module (CEM) for bronchiolitis management, adapted from Clinical Evidence (BMJ Publishing Group) and integrated into the hospital CPOE. CPOE users were medical trainees under the supervision of staff physicians working in the infant ward. Use of antibiotics, bronchodilators and corticosteroids; disease severity; length of hospital admission; and trainee use and perception of the CEM were measured before and after CEM introduction.
Results
334 paediatric inpatients age 2 weeks to 2 years, with a clinical diagnosis of bronchiolitis; 147 children the year preceding and 187 children the year following introduction of a Clinical Evidence Module (CEM). The percentage of patients receiving antibiotics fell from 35% to 22% (relative decrease 37%) following the introduction of the CEM (p = 0.016). Bronchodilator use was high but following the CEM patients no longer received more than one variety. Steroid usage and length of hospitalisation were low and unaffected. Trainees found the CEM to be educational.
Conclusion
Readily accessible clinical evidence at the point of care was associated with a significant decrease in antibiotic use and an end to multiple bronchodilator use. The majority of physician trainees found the CEM to be a useful educational tool.
doi:10.1186/1471-2431-7-4
PMCID: PMC1794224  PMID: 17250764
4.  Cloxacillin versus vancomycin for presumed late-onset sepsis in the Neonatal Intensive Care Unit and the impact upon outcome of coagulase negative staphylococcal bacteremia: a retrospective cohort study 
BMC Pediatrics  2005;5:49.
Background
Coagulase negative staphylococcus (CONS) is the main cause of late-onset sepsis in Neonatal Intensive Care Units (NICU). Although CONS rarely causes fulminant sepsis, vancomycin is frequently used as empiric therapy. Indiscriminate use of vancomycin has been linked to the emergence of vancomycin resistant organisms. The objective of this study was to compare duration of CONS sepsis and mortality before and after implementation of a policy of selective vancomycin use and compare use of vancomycin between the 2 time periods.
Methods
A retrospective study was conducted of infants ≥4 days old, experiencing signs of sepsis with a first positive blood culture for CONS, during two 12-month periods. Late-onset sepsis was treated empirically with vancomycin and gentamicin during period 1, and cloxacillin and gentamicin during period 2. The confidence interval method was used to assess non-inferiority of the outcomes between the two study groups.
Results
There were 45 episodes of CONS sepsis during period 1 and 37 during period 2. Duration of sepsis was similar between periods (hazard ratio of 1.00, 95%CI: 0.64, 1.57). One death during period 2 was possibly related to CONS sepsis versus none in period 1. Vancomycin was used in 97.8% of episodes in period 1 versus 81.1% of episodes in period 2.
Conclusion
Although we failed to show non-inferiority of duration of sepsis in the cloxacillin and gentamicin group compared to the vancomycin and gentamicin group, duration of sepsis was clinically similar. Restricting vancomycin for confirmed cases of CONS sepsis resistant to oxacillin appears effective and safe, and significantly reduces vancomycin use in the NICU.
doi:10.1186/1471-2431-5-49
PMCID: PMC1343548  PMID: 16375769
5.  Assessing the quality of reports of randomized trials in pediatric complementary and alternative medicine 
BMC Pediatrics  2002;2:2.
Objective
To evaluate the quality of reports of complementary and alternative medicine (CAM) randomized controlled trials (RCTs) in the pediatric population. We also examined whether there was a change in the quality of reporting over time.
Methods
We used a systematic sample of 251 reports of RCTs that used a CAM intervention. The quality of each report was assessed using the number of CONSORT checklist items included, the frequency of unclear allocation concealment, and a 5-point quality assessment instrument.
Results
Nearly half (40%) of the CONSORT checklist items were included in the reports, with an increase in the number of items included. The majority (81.3%) of RCTs reported unclear allocation concealment with no significant change over time. The quality of reports achieved approximately 40% of their maximum possible total score as assessed with the Jadad scale with no change over time. Information regarding adverse events was reported in less than one quarter of the RCTs (22%) and information regarding costs was mentioned in only a minority of reports (4%).
Conclusions
RCTs are an important tool for evidence based health care decisions. If these studies are to be relevant in the evaluation of CAM interventions it is important that they are conducted and reported with the highest possible standards. There is a need to redouble efforts to ensure that children and their families are participating in RCTs that are conducted and reported with minimal bias. Such studies will increase their usefulness to a board spectrum of interested stakeholders.
doi:10.1186/1471-2431-2-2
PMCID: PMC99046  PMID: 11914145

Results 1-5 (5)