Comeri 1985.
| Methods | Randomised, double blind, active control, No placebo group Baseline PI = moderate or severe pain (82.5 mm on a 100 mm VAS) Self assessment at t = 0, 0.5, 1 hr | |
| Participants | N=148 Dipyrone 1 g + pitofenon 0.4 mg + fenpiverine 0.04 mg, n=50 Diclofenac 75 mg, n=48 Indomethacin 50 mg, n= 50 | |
| Interventions | Dipyrone 1 g + pitofenon 0.4 mg + fenpiverine 0.04 mg Diclofenac 75 mg Indomethacin 50 mg Single IM dose, 1 hr If the PI had not decreased by 50% of the initial value at 60 mins after the first dose, the patient received a second injection of the same drug in a double blind manner. Any patient not experiencing a decrease of PI after the second dose was removed from the study | |
| Outcomes | PI (VAS 0‐100 mm) PR > 50% at 30mins: Dipyrone=28/50 Diclofencac=38/48 Indomethacin = 34/50 | |
| Notes | No AEs were reported by any patient Single dose AEs: 15 patients dropped out: diclofenac (3), indomethacin (6), dipyrone (6) QS=4 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement | 
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |