Table 3.
Study Outcomes for High and Low Dose Fentanyl Sublingual Spray (FSS) Groups
| High Dose Group, mean (SD) [95% CI] | Low Dose Group, mean (SD) [95% CI] | |||||||
|---|---|---|---|---|---|---|---|---|
| Variable | First walk | Second walk | Difference | P-Value* | First walk | Second walk | Difference | P-Value* |
| Modified Borg Scale: Dyspnea Intensity (primary outcome) | ||||||||
| Beginning of walk | 0.6 (0.8) | 0.7 (1.0) | 0.1 (0.5) | 0.44 | 0.5 (0.7) | 0.4 (0.8) | −0.06 (0.6) | 0.84 |
| End of walk | 5.1 (1.1) | 3.8 (1.4) | −1.3 (1.6) | 5.1 (2.0) | 4.5 (2.1) | −0.5 (1.4) | ||
| Difference | 4.5 (1.7) | 3.1 (1.5) | −1.4 (1.6) [−2.4, −0.5] |
0.007 | 4.6 (1.7) | 4.1 (2.2) | −0.5 (1.6) [−1.3, 0.3] |
0.24 |
| Difference/distance walked (/100 m) | 1.5 (0.9) | 0.9 (0.7) | −0.6 (0.5) [−0.9, −0.3] |
<0.001 | 1.6 (0.9) | 1.3 (0.7) | −0.3 (0.5) [−0.6, −0.1] |
0.03 |
| Difference/min walked (/min) | 0.8 (0.3) | 0.5 (0.3) | −0.3 (0.3) [−0.4, −0.1] |
<0.001 | 0.8 (0.3) | 0.7 (0.4) | −0.1 (0.2) [−0.3, −0.008] |
0.05 |
| Modified Borg Scale: Dyspnea Unpleasantness | ||||||||
| Beginning of walk | 0.6 (0.8) | 0.7 (1.3) | 0.1 (0.7) | 0.94 | 0.4 (1.0) | 0.4 (1.0) | −0.03 (0.3) | >0.99 |
| End of walk | 3.9 (1.7) | 2.9 (1.9) | −1.0 (1.9) | 4.1 (2.4) | 3.4 (2.8) | −0.7 (1.3) | ||
| Difference | 3.3 (2.0) | 2.2 (1.8) | −1.0 (1.8) | 0.06 | 3.7 (2.1) | 3.0 (2.5) | −0.6 (1.4) | 0.10 |
| Walk distance (m) | 354.6 (155.8) | 398.3 (148.7) | 43.7 (30.0) [25.6, 61.8] |
0.001 | 343.2 (148.4) | 367.4 (159.6) | 24.2 (35.7) [5.8, 42.6 ] |
0.01 |
| Walk time (min) | 6.2 (1.9) | 6.7 (1.7) | 0.5 (0.4) [0.3, 0.7] |
<0.001 | 6.0 (1.9) | 6.3 (1.8) | 0.3 (0.4) [0.18, 0.5] |
0.009 |
| Fatigue Borg Scale | ||||||||
| Beginning of walk | 2.8 (2.4) | 2.3 (1.7) | −0.5 (1.5) | 0.31 | 2.4 (2.6) | 1.9 (2.3) | −0.5 (1.1) | 0.10 |
| End of walk | 4.8 (1.9) | 3.3 (1.9) | −1.5 (2.7) | 4.1 (1.8) | 3.5 (1.9) | −0.4 (1.2) | ||
| Difference | 2.0 (3.0) | 1.0 (1.0) | −1.0 (2.8) | 0.13 | 1.4 (2.5) | 1.5 (2.3) | 0.2 (1.6) | 0.64 |
| Heart Rate (beats/min) | ||||||||
| Beginning of walk | 90.5 (16.6) | 87.7 (13.5) | −2.9 (10.2) | 0.38 | 77.6 (13.9) | 79.5 (15.4) | 1.9 (6.3) | 0.19 |
| End of walk | 100.6 (19.2) | 101.2 (22.1) | 0.5 (16.5) | 87.5 (26.8) | 88.3 (29.6) | 0.8 (8.8) | ||
| Difference | 10.1 (16.0) | 13.5 (16.7) | 3.4 (12.5) | 0.15 | 9.9 (23.25) | 8.8 (22.9) | −1.1 (8.3) | 0.64 |
| Respiratory Rate (breaths/min) | ||||||||
| Beginning of walk | 17.4 (3.5) | 16.0 (3.7) | −1.4 (3.3) | 0.17 | 15.5 (3.4) | 15.4 (4.0) | −0.1 (2.5) | 0.95 |
| End of walk | 21.1 (3.0) | 20.9 (4.9) | −0.2 (4.1) | 20.4 (6.2) | 18.8 (5.2) | −1.6 (4.0) | ||
| Difference | 3.7 (4.1) | 4.9 (5.3) | 1.2 (6.4) | 0.72 | 4.9 (4.4) | 3.5 (4.1) | −1.5 (3.8) | 0.15 |
| Systolic Blood pressure (mm Hg) | ||||||||
| Beginning of walk | 130.9 (19.4) | 127.2 (18.3) | −3.6 (15.0) | 0.48 | 121.8 (18.7) | 117.5 (16.9) | −4.4 (12.7) | 0.20 |
| End of walk | 142.4 (15.9) | 145.7 (14.6) | 3.3 (10.1) | 131.4 (13.7) | 136.3 (14.1) | 4.9 (11.4) | ||
| Difference | 11.5 (12.7) | 18.5 (9.3) | 6.9 (13.7) | 0.10 | 9.5 (18.2) | 18.8 (14.1) | 9.3 (20.0) | 0.10 |
| Diastolic Blood pressure (mm Hg) | ||||||||
| Beginning of walk | 76.6 (11.7) | 77.7 (6.8) | 1.1 (7.0) | 0.62 | 71.8 (10.6) | 73.9 (11.0) | 2.2 (6.0) | 0.17 |
| End of walk | 81.5 (8.6) | 85.9 (6.5) | 4.4 (6.1) | 75.4 (10.7) | 78.2 (13.3) | 2.8 (9.0) | ||
| Difference | 4.9 (7.1) | 8.2 (7.1) | 3.3 (6.7) | 0.11 | 3.6 (8.8) | 4.2 (7.4) | 0.7 (10.1) | 0.44 |
| Oxygen Saturation (%) | ||||||||
| Beginning of walk | 97.7 (1.4) | 96.7 (2.1) | −1 (1.2) | 0.02 | 97.2 (2.0) | 97.2 (2.2) | 0.1 (1.5) | 0.95 |
| End of walk | 97.9 (2.0) | 97.6 (1.9) | −0.3 (1.0) | 97.9 (2.2) | 97.9 (2.8) | 0 (1.4) | ||
| Difference | 0.2 (1.2) | 0.9 (1.0) | 0.7 (1.7) | 0.21 | 0.7 (2.0) | 0.7 (1.5) | −0.1 (1.7) | 0.87 |
| Neurocognitive Testing | ||||||||
| Before medication | Post second walk test | Difference | P-value* | Before medication | Post second walk test | Difference | P-value* | |
| Tapping | 42.1 (9.9) | 48.9 (11.2) | 6.9 (8.6) | 0.003 | 46.4 (8.4) | 49.8 (9.1) | 3.4 (6.3) | 0.01 |
| Arithmetic | 88.7 (42.5) | 84.8 (47.4) | −3.9 (27.2) | 0.56 | 52.8 (31.4) | 58.1 (38.3) | 5.2 (19.6) | 0.73 |
| Reverse digits | 4.5 (2.1) | 3.9 (2.4) | −0.5 (1.6) | 0.36 | 4.1 (2.1) | 4.9 (2.6) | 0.8 (1.7) | 0.10 |
| Visual | 5.4 (1.2) | 5.4 (1.3) | 0 (1.4) | >0.99 | 5.7 (0.8) | 5.5 (0.9) | −0.1 (0.9) | >0.99 |
Abbreviations: CI, confidence interval; FSS, fentanyl sublingual spray; SD, standard deviation
*
Wilcoxon signed rank test was used for all comparisons between the first and second shuttle walk test.