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Immediate rescue designs in pediatric analgesic trials: a systematic review and meta-analysis.

ABSTRACT: Designing analgesic clinical trials in pediatrics requires a balance between scientific, ethical, and practical concerns. A previous consensus group recommended immediate rescue designs using opioid sparing as a surrogate measure of analgesic efficacy. The authors summarize the performance of rescue analgesic designs in pediatric trials of four commonly used classes of analgesics: opioids, nonsteroidal antiinflammatory drugs, acetaminophen, and local anesthetics.MEDLINE, Embase, CINAHL, The Cochrane Library, and Web of science were searched in April 2013. The 85 studies selected were randomized or controlled clinical trials using immediate rescue paradigms in postoperative pain settings. A random-effects meta-analysis was used to synthesize predefined outcomes using Hedges' g. Difference between the means of the treatment arms were also expressed as a percentage of the corresponding value in the placebo group (placebo-treatment/placebo). Distributions of pain scores in study and control groups and relationships between opioid sparing and pain scores were examined.For each of the four study drug classes, significant opioid sparing was demonstrated in a majority of studies by one or more of the following endpoints: (1) total dose (milligram per kilogram per hour), (2) percentage of children requiring rescue medication, and (3) time to first rescue medication (minutes). Pain scores averaged 2.4/10 in study groups, 3.4/10 in control groups.Opioid sparing is a feasible pragmatic endpoint for pediatric pain analgesic trials. This review serves to guide future research in pediatric analgesia trials, which could test whether some specific design features may improve assay sensitivity while minimizing the risk of unrelieved pain.

SUBMITTER: Kossowsky J

PROVIDER: S-EPMC4305029 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Immediate rescue designs in pediatric analgesic trials: a systematic review and meta-analysis.

Kossowsky Joe J Donado Carolina C Berde Charles B CB

Anesthesiology 20150101 1

<h4>Background</h4>Designing analgesic clinical trials in pediatrics requires a balance between scientific, ethical, and practical concerns. A previous consensus group recommended immediate rescue designs using opioid sparing as a surrogate measure of analgesic efficacy. The authors summarize the performance of rescue analgesic designs in pediatric trials of four commonly used classes of analgesics: opioids, nonsteroidal antiinflammatory drugs, acetaminophen, and local anesthetics.<h4>Methods</h ...[more]

PMID: 25222831

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Project description:BackgroundDigital learning designs have the potential to support teaching and learning within higher education. However, the research on digital learning designs within physiotherapy education is limited. This study aims to identify and investigate the effectiveness of digital learning designs in physiotherapy education.MethodsThe study was designed as a systematic review and meta-analysis of randomized and non-randomized trials. A search of eight databases on digital learning designs and technology was conducted. Study selection, methodology and quality assessment were performed independently by three reviewers. The included studies were mapped according to the types of digital interventions and studies. For similar interventions, the learning effects were calculated using meta-analyses.ResultsAltogether, 22 studies were included in the review (17 randomized controlled trials and five cohort studies). A blended learning design was used in 21 studies, a flipped classroom model in five and a distance learning design in one. Altogether, 10 of the 22 articles were included in meta-analyses, which showed statistically significant effects for flipped classrooms on knowledge acquisition (standardized mean difference [SMD]: 0.41; 95% confidence interval [CI]: 0.20, 0.62), for interactive websites or applications (apps) on practical skills (SMD: 1.07; 95% CI: 0.71,1.43) and for students self-produced videos on a practical skill in a cervical spine scenario (SMD: 0.49; 95% CI: 0.06, 0.93). Overall, the effects indicated that blended learning designs are equally as or more effective than traditional classroom teaching to achieve learning outcomes. Distance learning showed no significant differences compared to traditional classroom teaching.ConclusionsThe current findings from physiotherapy education indicate that digital learning designs in the form of blended learning and distance learning were equally or more effective compared to traditional teaching. The meta-analyses revealed significant effects on student learning in favour of the interventions using flipped classrooms, interactive websites/apps and students self-produced videos. However, these results must be confirmed in larger controlled trials. Further, research should investigate how digital learning designs can facilitate students' learning of practical skills and behaviour, learning retention and approaches to studying as well as references for teaching and learning in digital learning environments.

Project description:BACKGROUND:Pediatric Phase I cancer trials are critical for establishing the safety and dosing of anti-cancer treatments in children. Their implementation, however, must contend with the rarity of many pediatric cancers and limits on allowable risk in minors. The aim of this study is to describe the risk and benefit for pediatric cancer Phase I trials. METHODS AND FINDINGS:Our protocol was prospectively registered in PROSPERO (CRD42015015961). We systematically searched Embase and PubMed for solid and hematological malignancy Phase I pediatric trials published between 1 January 2004 and 1 March 2015. We included pediatric cancer Phase I studies, defined as "small sample size, non?randomized, dose escalation studies that defined the recommended dose for subsequent study of a new drug in each schedule tested." We measured risk using grade 3, 4, and 5 (fatal) drug-related adverse events (AEs) and benefit using objective response rates. When possible, data were meta-analyzed. We identified 170 studies meeting our eligibility criteria, accounting for 4,604 patients. The pooled overall objective response rate was 10.29% (95% CI 8.33% to 12.25%), and was lower in solid tumors, 3.17% (95% CI 2.62% to 3.72%), compared with hematological malignancies, 27.90% (95% CI 20.53% to 35.27%); p < 0.001. The overall fatal (grade 5) AE rate was 2.09% (95% CI 1.45% to 2.72%). Across the 4,604 evaluated patients, there were 4,675 grade 3 and 4 drug-related AEs, with an average grade 3/4 AE rate per person equal to 1.32. Our study had the following limitations: trials included in our review were heterogeneous (to minimize heterogeneity, we separated types of therapy and cancer types), and we relied on published data only and encountered challenges with the quality of reporting. CONCLUSIONS:Our meta-analysis suggests that, on the whole, AE and response rates in pediatric Phase I trials are similar to those in adult Phase I trials. Our findings provide an empirical basis for the refinement and review of pediatric Phase I trials, and for communication about their risk and benefit.

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Immediate rescue designs in pediatric analgesic trials: a systematic review and meta-analysis.

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Immediate rescue designs in pediatric analgesic trials: a systematic review and meta-analysis.

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