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Outcome domains reported by Chinese randomized controlled trials of postoperative analgesia for children

Date and Location




Saturday 21 September 2013 - 10:30 - 12:00


Presenting author and contact person

Presenting author

Kehu Yang

Contact person

Kehu Yang
Rao Sun
Abstract text
Background: Standardization of outcome domains and measures in pediatric pain randomized controlled trials (RCTs) would streamline designing and reviewing research protocols and articles, simplify and strengthen systematic reviews, and help clinicians make treatment decisions. The Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (PedIMMPACT) has recommended 6 core domains be considered in clinical trials of pediatric acute pain (Table 1). (J Pain. 2008 Sep;9(9):771-83) Objectives: To explore the distribution of outcome domains reported by Chinese RCTs of postoperative analgesia in the pediatric population, and determine whether they followed the PedIMMPACT recommendation. Methods: Four Chinese medical databases, including Chinese Biomedicine Literature Database (CBM) were searched using the search terms “child”, “pediatrics”, “infant”, “postoperative pain”, “postoperative analgesia” and “randomized” in July 2012 for RCTs of postoperative analgesia for children. Outcome domains of included RCTs were recorded. MetaAnalyst 3.13 software was used to analyze data. Results: Our study included 296 relevant RCTs, with 10 outcome domains being reported (Table 1). Each RCT reported a median of 3 (range: 1-7) outcome domains. Pain intensity was reported by the most RCTs, and followed by symptoms and adverse events, vital signs and effective analgesic time. For the six outcome domains PedIMMPACT had recommended, none of included RCTs reported all of them; most RCTs (266/296, 90%) reported less than 4 domains; 2 RCTs (1%), however, even reported none of them. Conclusions: Although most RCTs reported pain intensity, an important outcome for acute pain trials, other patient-important outcomes, such as patient satisfaction and physical recovery were reported at a very low proportion. Researchers should pay more attention on patient-important outcomes, and follow the PedIMMPACT recommendation when designing and conducting RCTs of postoperative analgesia in the pediatric population.