Table 4 Comparison of characteristics of PDSS in routine clinical practice and formal clinical trials [5-8]
Characteristic | Routine clinical practice | Formal clinical trials |
|---|---|---|
Rate of PDSS (% of injections) | 0.07% | 0.07–0.09% |
Rate of PDSS (% of patients) | 0.46–1.03% | 1.4–2.0% |
Cases starting within 60 minutes of injection | 91% | 80% |
Cases requiring hospitalisation | 65% | 77% |
Cases requiring medication/specific treatment | 31% | 37% |
Cases showing recovery within 72 hours | 88% | 100% |
Cases involving delirium-related AEs | 86% | 97% |
Cases involving sedation-related AEs | 89% | 87% |
Cases involving delirium & sedation-related AEs | 74% | 83% |