Table 2.
Main results. Values are numbers (percentages) unless stated otherwise
| Haloperidol plus promethazine group (n=160) | Haloperidol group (n=156) | Relative risk (95% CI) | Difference in risk (95% CI) | |
|---|---|---|---|---|
| By 20 minutes | ||||
| Tranquil/asleep (primary outcome) | 115 (72) | 86 (55) | 1.30 (1.10 to 1.55) | 16.7 (6.3 to 27.2) |
| Asleep | 31 (19) | 13 (8) | 2.33 (1.26 to 4.27) | 11.0 (3.5 to 18.5) |
| Unknown | 3 (2) | 2 (1) | ||
| By 40 minutes | ||||
| Tranquil/asleep | 129 (81) | 118 (76) | 1.07 (0.95 to 1.20) | 5.0 (−4.1 to 14.1) |
| Asleep | 57 (36) | 54 (35) | 1.03 (0.76 to 1.39) | 1.0 (−9.5 to 11.5) |
| Unknown | 3 (2) | 2 (1) | ||
| By 60 minutes | ||||
| Tranquil/asleep | 139 (87) | 127 (81) | 1.07 (0.97 to 1.17) | 5.5 (−2.6 to 13.5) |
| Asleep | 77 (48) | 77 (49) | 0.98 (0.78 to 1.22) | −1.2 (−12.3 to 9.8) |
| Unknown | 3 (2) | 2 (1) | ||
| By 120 minutes | ||||
| Tranquil/asleep | 146 (91) | 138 (89) | 1.03 (0.96 to 1.11) | 2.8 (−3.9 to 9.4) |
| Asleep | 97 (61) | 94 (60) | 1.01 (0.84 to 1.20) | 0.4 (−10.4 to 11.2) |
| No additional tranquillising drugs | 152 (95) | 143 (92) | 1.04 (0.98 to 1.10) | 3.3 (−2.2 to 8.8) |
| Restraints not needed | 122 (76) | 111 (71) | 1.07 (0.94 to 1.22) | 5.1 (−4.6 to 14.8) |
| Unknown | 3 (2) | 2 (1) | ||
| Within 24 hours | ||||
| No other episode of aggression | 129 (81) | 124 (80) | 1.01 (0.91 to 1.13) | 1.1 (−7.7 to 10.0) |
| Unknown | 6 (4) | 12 (8) | ||
| Doctor not called to see patient | 123 (77) | 102 (65) | 1.18 (1.02 to 1.36) | 11.5 (1.7 to 21.4) |
| Unknown | 7 (4) | 11 (7) | ||
| Accept oral drugs* | 132 (84) | 129 (84) | 0.97 (0.88 to 1.06) | −3.0 (−10.9 to 4.9) |
| Unknown | 11 (7) | 11 (7) | ||
| Mean (SD) chlorpromazine equivalents (mg) | 245 (194) | 234 (182) | Mann-Whitney U=11885.500; P=0.46 | |
| Serious adverse effect† | 1 (1) | 11 (7) | 0.09 (0.01 to 0.68) | −6.4 (−10.6 to −2.2) |
| By 2 weeks | ||||
| Discharged | 62 (39) | 73 (47) | 0.83 (0.64 to 1.07) | −8.0 (−18.9 to 2.8) |
| Unknown | 3 (2) | 3 (2) | ||
*Two patients in each group excluded as not prescribed oral drugs.
†Patients with unknown outcome excluded from analysis.