Statistical measures
| Continuous summary outcome | Mean and SD |
| The outcome | Visual Analogue Scale (VAS) scores 60 min after study drug administration |
| The values assumed for outcomes in Each group | Mean VAS for control group 50 mm (5 cm) Mean VAS for the experimental group 40 mm (4 cm) |
| The statistical test | T-test comparing two independent means of continuous outcomes |
| Alpha error | Two-tailed p value <0.05 |
| Power | 0.8 |
| The calculated sample size per group Both assuming no loss of data | 64 per group |