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 anti-inflammatory drugs, acetaminophen, and local anesthetics.
What did the study involve?
A search in MEDLINE, Embase, CINAHL, The Cochrane Library, and Web of science on April 2013 was performed. 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.
Collaborating Research Groups
The study was performed within the Department of Anesthesiology, Perioperative & Pain Medicine.
Related Publications
Kossowsky J, Donado C, Berde CB. Immediate rescue designs in pediatric analgesic trials: a systematic review and meta-analysis. Anesthesiology. 2015 Jan;122(1):150-71. http://www.ncbi.nlm.nih.gov/pubmed/25222831
