Summary of findings for the main comparison. Droperidol versus placebo.
| Droperidol versus placebo | ||||||
|
Patient or population: acute psychosis Setting: inpatient Intervention: droperidol Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with droperidol | |||||
| Tranquillisation or asleep: tranquillised/sleep ‐ by around 30 minutes | Moderate | RR 1.18 (1.05 to 1.31) | 227 (1 RCT) | ⊕⊕⊕⊕ High 1 | 'Moderate' control risk approximately that of trial population. | |
| 800 per 1000 | 944 per 1000 (840 to 1000) | |||||
| Global state: use of additional medication ‐ by 60 minutes after initial adequate sedation until ED discharge (various psychotropic drugs) | Moderate | RR 0.55 (0.36 to 0.85) | 227 (1 RCT) | ⊕⊕⊕⊕ High 1,2 | 'Moderate' control risk approximately that of trial population. | |
| 400 per 1000 | 220 per 1000 (144 to 340) | |||||
| Adverse effects ‐ cardiovascular ‐ arrhythmia | Moderate | RR 0.34 (0.01 to 8.31) | 227 (1 RCT) | ⊕⊕⊕⊝ Moderate 1,3 | 'Moderate' control risk approximately that of trial population. | |
| 10 per 1000 | 3 per 1000 (0 to 83) | |||||
| Adverse effects ‐ respiratory ‐ airway obstruction | Moderate | RR 0.62 (0.15 to 2.52) | 227 (1 RCT) | ⊕⊕⊝⊝ Low 3,4 | 'Moderate' control risk approximately that of trial population. | |
| 40 per 1000 | 25 per 1000 (6 to 101) | |||||
| Service use: person able to be discharged home | Moderate | RR 1.16 (0.90 to 1.48) | 227 (1 RCT) | ⊕⊕⊕⊕ High 1 | 'Moderate' control risk approximately that of trial population. | |
| 500 per 1000 | 580 per 1000 (450 to 740) | |||||
| Mental state ‐ improvement | Study population | Not estimable | (0 studies) | ‐ | No trial reported this important outcome. | |
| Not pooled | Not pooled | |||||
| Economic: direct costs | Study population | Not estimable | (0 studies) | ‐ | No trial reported this important outcome. | |
| Not pooled | Not pooled | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; ED: emergency department; RCT: randomised controlled trial; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. | ||||||
1 Risk of bias: rated 'not serious' (no downgrade) ‐ clear reporting of good methods.
2 Indirectness: rated 'not serious' (no downgrade) ‐ but proxy outcome for 'Another episode of aggression by 24 hours'.
3 Imprecision: rated 'serious' (downgraded by 1) ‐ few events, wide confidence intervals.
4 Indirectness: rated 'serious' (downgraded by 1) ‐ respiratory obstruction proxy measure ‐ not 'death'.