Table 3. Change in Physiologic Variables and Neurocognitive Testing Between with Fentanyl Buccal Tablet and Placebo.
| Variables | Baseline walk test, mean (SD) | Second walk test, mean (SD) | Difference between first and second walk test, mean (95% CI)a | |||
|---|---|---|---|---|---|---|
| Placebo | FBT | Placebo | FBT | Placebo | FBT | |
| Heart rate | ||||||
| 0 minutes | 82.9 (16) | 90.6 (12.9) | 83.9 (16.3) | 92.6 (12.8) | 1 (-4, 6) | 2 (-3.8, 7.8) |
| 6 minutes | 83.5 (19.6) | 97.9 (13.7) | 88.5 (21) | 94.6 (11.9) | 5 (-10, 20) | -3.3 (-8.4, 1.7) |
| Δ (6-0) minutes | 0.6 (16.2) | 7.3 (9.2) | 4.6 (11.6) | 2 (5.1) | 4 (-14.1, 22.1) | -5.3 (-13.4, 2.7) |
| Respiratory rate | ||||||
| 0 minutes | 17.5 (4.6) | 17.7 (3.1) | 17.5 (3.4) | 17.9 (2.9) | 0.1 (-2.4, 2.5) | 0.2 (-1.2, 1.6) |
| 6 minutes | 20.3 (5.2) | 20.4 (2.9) | 19.3 (4) | 18.1 (2.9) | -1 (-3.5, 1.5) | -2.3 (-3.9, -0.8) |
| Δ (6-0) minutes | 2.8 (3.4) | 2.8 (2.9) | 1.7 (3.4) | 0.2 (1.2) | -1.1 (-3.5, 1.3) | -2.6 (-4.7, -0.4) |
| Systolic blood pressure | ||||||
| 0 minutes | 115.1 (11.6) | 121.9 (12.7) | 121.3 (15.7) | 121.9 (14.5) | 6.2 (-3.8, 16.2) | 0 (-7.1, 7.1) |
| 6 minutes | 123.1 (18.1) | 131 (13.1) | 122.4 (13.7) | 129.9 (10.4) | -0.7 (-9.8, 8.4) | -1.1 (-11.2, 9) |
| Δ (6-0) minutes | 8 (15.7) | 9.1 (10.5) | 1.1 (16.5) | 8 (10.4) | -6.9 (-20.8, 7) | -1.1 (-13.6, 11.3) |
| Diastolic blood pressure | ||||||
| 0 minutes | 71 (7.4) | 77.1 (10.2) | 76.2 (12.1) | 77.3 (9.1) | 5.2 (0.5, 9.8) | 0.2 (-2.7, 3.1) |
| 6 minutes | 78.4 (8.8) | 77.9 (9.8) | 77.5 (12.3) | 75.4 (8.4) | -0.8 (-5.7, 4.1) | -2.4 (-6.8, 1.9) |
| Δ (6-0) minutes | 7.4 (7.3) | 0.8 (2.9) | 1.4 (5.3) | -1.9 (4.9) | -6 (-11.7, -0.3) | -2.7 (-7, 1.7) |
| Oxygen saturation | ||||||
| 0 minutes | 97.1 (2.2) | 97.9 (1.5) | 97.3 (1.2) | 98.2 (0.8) | 0.2 (-1.2, 1.5) | 0.3 (-0.5, 1.2) |
| 6 minutes | 97.4 (1.8) | 98.3 (1.9) | 96.8 (2.5) | 97.9 (1.9) | -0.5 (-1.9, 0.9) | -0.4 (-1.5, 0.6) |
| Δ (6-0) minutes | 0.1 (2.8) | 0.4 (1.7) | -0.5 (2.2) | -0.3 (1.4) | -0.6 (-3, 1.8) | -0.8 (-2.2, 0.6) |
| Neurocognitive testing | ||||||
| Tapping (average of 3 trials) | 35.7 (10.9) | 39.1 (8.5) | 41.8 (12.2) | 43.2 (7.7) | 6.2 (-1.2, 13.5) | 4 (0.5, 7.5) |
| Arithmetic | 62 (40.2) | 64.4 (76) | 59.1 (40.1) | 102.9 (191.9) | -2.9 (-11.6, 5.8) | 38.4 (-51, 127.9) |
| Reverse | 4.4 (2.1) | 4.6 (1.9) | 4.4 (2.5) | 3.8 (2) | 0 (-1, 1) | -0.8 (-2.3, 0.7) |
| Visual | 5.7 (0.9) | 6 (0) | 5.5 (1) | 5.6 (0.9) | -0.2 (-0.6, 0.2) | -0.4 (-1.1, 0.2) |
Abbreviations: CI, confidence interval; FBT, fentanyl buccal tablet; SD, standard deviation
a
Statistically significant values are highlighted in bold