Table 2.
Analysis of change from baseline in VAS pain intensity up to 10 min (ITT population)
| Population | Time point (min) | Estimated mean change from baseline (95% confidence interval) | Estimated treatment effect (95% confidence interval) | |
|---|---|---|---|---|
| Methoxyflurane | Standard analgesic treatment | |||
| All patients (N = 270) | 3 | − 6.29 (− 7.94, − 4.64) | − 2.56 (− 4.21, − 0.91) | − 3.73 (− 6.06, − 1.40)a |
| 5 | − 14.85 (− 17.16, − 12.54) | − 7.99 (− 10.30, − 5.68) | − 6.86 (− 10.13, − 3.59)a | |
| 10 | − 23.04 (− 25.84, − 20.23) | − 15.80 (− 18.60, − 13.00) | − 7.24 (− 11.20, − 3.27)a | |
| Primary endpoint | Overall | − 14.73 (− 16.77, − 12.69) | − 8.78 (− 10.82, − 6.75) | − 5.94 (− 8.83, − 3.06)a |
| Moderate pain (N = 177) | 3 | − 7.07 (− 9.16, − 4.99) | − 3.45 (− 5.48, − 1.42) | − 3.63 (− 6.54, − 0.72)a |
| 5 | − 14.70 (− 17.58, − 11.82) | − 8.96 (− 11.75, − 6.16) | − 5.75 (− 9.76, − 1.73)a | |
| 10 | − 23.57 (− 26.97, − 20.18) | − 15.04 (− 18.34, − 11.75) | − 8.53 (− 13.26, − 3.80)a | |
| Co-primary endpoint | Overall | − 15.12 (− 17.68, − 12.55) | − 9.15 (− 11.64, − 6.66) | − 5.97 (− 9.55, − 2.39)a |
| Severe pain (N = 93) | 3 | − 4.69 (− 7.27, − 2.11) | − 0.96 (− 3.68, 1.76) | − 3.73 (− 7.48, 0.024) |
| 5 | − 14.89 (− 18.80, − 10.99) | − 6.26 (− 10.38, − 2.13) | − 8.64 (− 14.32, − 2.96)a | |
| 10 | − 21.87 (− 26.93, − 16.81) | − 17.62 (− 22.96, − 12.28) | − 4.25 (− 11.61, 3.12) | |
| Exploratory endpoint | Overall | − 13.82 (− 17.22, − 10.42) | − 8.28 (− 11.87, − 4.69) | − 5.54 (− 10.49, − 0.59)a |
ITT intent-to-treat, VAS visual analogue scale
aMean difference significant at the 0.05 level (Bonferroni adjustment for multiple comparisons)