Table 2.
Analysis of Change from Baseline in VAS Pain Intensity (Severe Pain Subgroup, ITT Population)
| Endpoint | Time Point (min) | Mean Change from Baseline (95% Confidence Interval)a | Estimated Treatment Effect (95% Confidence Interval) | p-value | |
|---|---|---|---|---|---|
| Methoxyflurane | Standard Analgesic Treatment | ||||
| Primary Endpoint | 3 | −4.69 (−7.27, −2.11) | −0.96 (−3.68, 1.76) | −3.73 (−7.48, 0.02) | 0.051 |
| 5 | −14.89 (−18.80, −10.99) | −6.26 (−10.38, −2.13) | −8.64 (−14.32, −2.96) | 0.003b | |
| 10 | −21.87 (−26.93, −16.81) | −17.62 (−22.96, −12.28) | −4.25 (−11.61, 3.11) | 0.254 | |
| Overall | −13.82 (−17.22, −10.42) | −8.28 (−11.87, −4.69) | −5.54 (−10.48, −0.59) | 0.029b | |
| Secondary Endpoint | 15 | −27.25 (22.23) | −26.81 (17.92) | −0.44 (−8.86, 7.98) | 0.917 |
| 20 | −33.43 (22.49) | −31.45 (20.05) | −1.98 (−11.04, 7.08) | 0.665 | |
| 25 | −38.41 (23.34) | −38.85 (19.16) | 0.44 (−8.73, 9.61) | 0.924 | |
| 30 | −43.96 (23.42) | −43.88 (18.96) | −0.08 (−9.23, 9.08) | 0.986 | |
Notes: Based on estimated marginal means. aMean change from baseline (standard deviation) is presented for 15, 20, 25 and 30 min time points. bMean difference significant at the 0.05 level (Bonferroni adjustment for multiple comparisons).
Abbreviations: ITT, intention-to-treat; VAS, visual analog scale.