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. 2016 Dec 15;2016(12):CD002830. doi: 10.1002/14651858.CD002830.pub3

Summary of findings 3. Droperidol versus midazolam.

Droperidol versus midazolam
Patient or population: acute psychosis
Setting: inpatient
Intervention: droperidol
Comparison: midazolam
Outcomes Anticipated absolute effects* (95% CI) Relative effect
 (95% CI) No of participants
 (studies) Quality of the evidence
 (GRADE) Comments
Risk with midazolam Risk with droperidol
Tranquillisation or asleep: tranquillised/asleep ‐ by 30 minutes (at 10 minutes) Moderate RR 0.96
 (0.72 to 1.28) 153
 (1 RCT) ⊕⊕⊕⊕
 High 1 'Moderate' control risk approximately that of trial population.
550 per 1000 528 per 1000
 (396 to 704)
Global state: use of additional medication ‐ by 60 minutes after initial adequate sedation until ED discharge (various psychotropic drugs) Moderate RR 0.54 (0.24 to 1.20) 153
 (1 RCT) ⊕⊕⊕⊝
 Moderate 1,2 'Moderate' control risk approximately that of trial population.
190 per 1000 101 per 1000
 (42 to 224)
Adverse effects ‐ respiratory ‐ airway obstruction Moderate RR 0.13
 (0.01 to 2.55) 153
 (1 RCT) ⊕⊕⊝⊝
 Low 1,2,3 'Moderate' control risk approximately that of trial population.
40 per 1000 5 per 1000
 (0 to 102)
Adverse effects ‐ respiratory ‐ hypoxia Moderate RR 0.70
 (0.16 to 3.03) 153
 (1 RCT) ⊕⊕⊕⊝
 Moderate 1,2 'Moderate' control risk approximately that of trial population.
50 per 1000 35 per 1000
 (8 to 143)
Service use: person able to be discharged home Study population Not estimable (0 studies) No trial reported this important outcome.
Not pooled Not pooled
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 evidenceHigh 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 Imprecision: rated 'serious' (downgraded by 1) ‐ few events, wide confidence intervals.

3 Indirectness: rated 'serious' (downgraded by 1) ‐ respiratory obstruction proxy measure ‐ not 'death'.