Resnick 1984.
Methods | Allocation: unclear ‐ 'code in pharmacy', probably randomised. Design: unspecified. Blinding: double ‐ identical vials. Duration: 24 hours (re‐evaluated at 15 minutes after the initial injection and at 30 minute intervals for 3 hours). Settings: ED and Psychiatric Crisis Unit, Oregon Health Sciences University, Portland. |
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Participants | Diagnosis: psychotic ‐ unspecified. N = 27. Age: range 18 to 65 years. Sex: unspecified. History: admitted to ED of psychiatric unit with symptoms of acute agitation and achieved a score of ≥ 17 on a subset of 6 categories on the BPRS. Excluded: people who were intoxicated; had known sensitivity to droperidol or haloperidol; or showed evidence of active renal, hepatic or cardiac disease. |
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Interventions | 1. Droperidol5 mg IM. N = 11. 2. Haloperidol5 mg IM. N = 16. |
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Outcomes | Global state: needing additional injection, time to control, BPRS. Adverse effects. Adverse effects: EPS. Vital signs: blood pressure, pulse, respiration (no data) ‐ unable to use. |
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Notes | Predefined levels of BPRS (subset ‐ anxiety, tension, mannerisms and posturing, hostility, unco‐operativeness, excitement) to a score of > 15 used to instigate reinjection. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...haloperidol on a randomised basis from identical appearing vials..." Response: probably randomised. |
Allocation concealment (selection bias) | Unclear risk | Quote: "Packages of medication were identified only by a code which was kept in the pharmacy until the conclusion of the study." Response: unclear whether and how allocation concealment was assured. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "a double‐blind clinical comparison of droperidol and haloperidol was undertaken". Response: personnel and participants were probably blind to the interventions. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if blinding of outcome assessment was carried out. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Of the 16 patients in the haloperidol group, 3 required a single injection and 13 required two or more injections... In droperidol group, 7 of the 11 patients required one injection and 4 required two injection". Response: low risk of attrition bias as the number of people initially randomised were all included in the final analysis. |
Selective reporting (reporting bias) | Low risk | All the stated outcomes were reported. |
Other bias | Unclear risk | Unclear. |