Table 2.
Apfel score by treatment in the phase 3 randomized clinical studies
| Apfel score n (%) |
Placebo | Oliceridine demand dose | Morphine | ||
|---|---|---|---|---|---|
| 0.1 mg | 0.35 mg | 0.5 mg | 1 mg | ||
| Hard tissue (orthopedic surgery-bunionectomy study) | |||||
| N | 79 | 76 | 79 | 79 | 76 |
| 0 | 0 | 0 | 0 | 0 | 0 |
| 1 | 1 (1.3) | 3 (3.9) | 2 (2.5) | 5 (6.3) | 0 |
| 2 | 14 (17.7) | 14 (18.4) | 20 (25.3) | 14 (17.7) | 21 (27.6) |
| 3 | 54 (68.4) | 52 (68.4) | 51 (64.6) | 53 (67.1) | 46 (60.5) |
| 4 | 10 (12.7) | 7 (9.2) | 6 (7.6) | 7 (8.9) | 9 (11.8) |
| Soft tissue (plastic surgery-abdominoplasty study) | |||||
| N | 83 | 77 | 79 | 80 | 82 |
| 0 | 0 | 0 | 0 | 0 | 0 |
| 1 | 0 | 0 | 0 | 0 | 0 |
| 2 | 3 (3.6) | 5 (6.5) | 6 (7.6) | 7 (8.8) | 6 (7.3) |
| 3 | 70 (84.3) | 63 (81.8) | 65 (82.3) | 67 (83.8) | 67 (81.7) |
| 4 | 10 (12.0) | 9 (11.7) | 8 (10.1) | 6 (7.5) | 9 (11.0) |
| Pooled studies | |||||
| N | 162 | 153 | 158 | 159 | 158 |
| 0 | 0 | 0 | 0 | 0 | 0 |
| 1 | 1 (0.6) | 3 (2.0) | 2 (1.3) | 5 (3.1) | 0 |
| 2 | 17 (10.5) | 19 (12.4) | 26 (16.5) | 21 (13.2) | 27 (17.1) |
| 3 | 124 (76.5) | 115 (73.4) | 116 (73.4) | 120 (75.5) | 113 (71.5) |
| 4 | 20 (12.3) | 16 (10.5) | 14 (8.9) | 13 (8.2) | 18 (11.4) |
Using a Cochran–Mantel–Haenszel raw mean score test to compare distribution across treatments—for hard tissue study, p = 0.584; soft tissue study, p = 0.663; pooled data, p = 0.307. Apfel score assesses a patient’s risk for postoperative nausea and vomiting based on known risk factors. Total score ranges from 0 to 4, with higher score indicating greater risk, and is the sum of positive responses to the following questions: is the patient female; does the patient have a history of postoperative nausea, vomiting, or motion sickness; is the patient a non-smoker; and does the patient have postoperative opioid use. In this study, all patients were considered as having postoperative opioid use