Related Experiment Video
Updated: Dec 21, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Ethics of randomized trials in pediatric surgery
Rebecca M Rentea1, Tolulope A Oyetunji2, Shawn D St Peter2
1Pediatric Surgery, Comprehensive Colorectal Center, Children's Mercy Hospital, 2401 Gillham Road, Kansas City, MO, 64108, USA. rrentea@cmh.edu.
Abstract:
To provide the best evidence-based treatment for children, and timely evaluation of innovations, the role of the pediatric surgeon's participation in randomized controlled trials (RCTs) and prospective comparative studies is required. The ethical considerations of pediatric surgical RCTs pose unique practical difficulties in the design and performance of clinical trials in children. There are several ethical issues unique to pediatric surgical RCTs: diseases with low volume, an inability to conduct Phase 1 and 2 trials, parental emotional involvement, difficulty with recruitment in surgical trials, volume, and modified study design, issues with permission vs. assent and investigator bias. This article reviews the ethical aspects unique to pediatric surgical RCTs and prospective comparative studies.Level of evidence: Level 3.
Related Concept Videos
Randomized Experiments
Simple randomization
Simple...
Psychosurgery
Historical Development of Psychosurgery
In the 1930s, Portuguese neurologist Antonio Egas Moniz introduced a surgical procedure designed...
Ethics in Research
Blinding
Ethics and Bioethics
Ethical Issues
Ethical Concerns in Healthcare:

