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Published on: July 7, 2023
Changes in Pain Score Associated With Clinically Meaningful Outcomes in Children With Acute Pain
Daniel S Tsze1, Gerrit Hirschfeld2, Carl L von Baeyer3
1Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.
Insights
This study defines meaningful pain score changes in children using validated scales. Findings help design better clinical trials for pediatric pain management.
Area of Science:
- Pediatric Pain Management
- Clinical Trial Design
- Patient-Reported Outcomes
Background:
- Assessing pain in children requires understanding changes linked to meaningful outcomes.
- Self-report pain scales are crucial but need clear interpretation of score changes.
Purpose of the Study:
- Determine pain score changes corresponding to minimum clinically significant difference (MCSD), ideal clinically significant difference (ICSD), and patient-perceived adequate analgesia (PPAA).
- Evaluate if these differences vary by initial pain intensity and patient characteristics.
Main Methods:
- Cross-sectional study involving children aged 4-17 years using Verbal Numerical Rating Scale (VNRS) and Faces Pain Scale-Revised (FPS-R).
- Receiver operating characteristic (ROC) curve methodology identified pain score changes associated with MCSD, ICSD, and PPAA.
- Children described pain changes and indicated need for additional analgesics.
Main Results:
- For VNRS, MCSD was 2/10 (20%), ICSD was 3/10 (44%), and PPAA was 2/10 (29%).
- For FPS-R, MCSD was 2/10 (33%), ICSD was 4/10 (60%), and PPAA was 4/10 (40%).
- Raw pain score changes increased with initial intensity, but percent reductions were stable; no significant differences by age, sex, or race/ethnicity.
Conclusions:
- Established patient-centered outcomes for pediatric pain trials.
- Findings are generalizable across diverse patient characteristics, aiding trial design and interpretation.
Background:
Identifying changes in pain score associated with clinically meaningful outcomes is necessary when using self-report measures to assess pain in children. We aimed to determine the changes in pain score associated with a minimum clinically significant difference (MCSD), ideal clinically significant difference (ICSD), and patient-perceived adequate analgesia (PPAA) and to evaluate for differences based on initial pain intensity and patient characteristics.
Methods:
This was a cross-sectional study of children 6 to 17 and 4 to 17 years old who were assessed using the Verbal Numerical Rating Scale (VNRS) and Faces Pain Scale-Revised (FPS-R), respectively. Children qualitatively described any endorsed change in pain score; those who received an analgesic were asked if they wanted additional analgesics to decrease their pain intensity. We used a receiver operating characteristic curve-based methodology to identify changes in pain score associated with "a little less" and "much less" pain (MCSD and ICSD, respectively) and patients declining additional analgesics because of adequate analgesia (PPAA).
Results:
We enrolled 431 children with painful conditions. For the VNRS, raw change and percent reductions in pain scores associated with MCSD, ICSD, and PPAA were 2/10 and 20%, 3/10 and 44%, and 2/10 and 29%, respectively, and for the FPS-R, 2/10 and 33%, 4/10 and 60%, and 4/10 and 40%, respectively. Raw change in pain scores increased with increasing initial pain intensity, but percent reductions remained stable. There were no significant differences based on patient characteristics such as age, sex, and race/ethnicity.
Conclusion:
Our findings provide patient-centered outcomes in children that are suitable for designing trials and are generalizable across patient characteristics.
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