Myles 1994.
Study characteristics | ||
Methods | Parallel, 48 h | |
Participants | PCA 36, control 36 Elective cardiac surgery | |
Interventions | PCA: morphine. Bolus/lockout/4 h limit: 1 mg/5 min/no limit Control: IV morphine nurse controlled infusion (dose range not specified) |
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Outcomes | Pain intensity, opioid usage, intensity of nausea, time to extubation, cortisol levels | |
Source of funding | PCA devices funded by Alfred Hospital Whole‐time Medical Specialists' Private Practice Fund | |
Notes | Withdrawals: control, n = 3: 2 deaths, 1 cerebrovascular accident QS = 2 (R = 1, DB = 0, W = 1) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not adequately described |
Allocation concealment (selection bias) | High risk | Blocked randomization with stratification ‐ study is not blinded, therefore allocation can be established |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Data of 69 participants analyzed: PCA 36 and control 33 (3 withdrawals all in the control group). Data for 16 participants incomplete, due to reasons apparently unrelated to interventions ‐ not clear whether included in analyses. Group assignment and methods of imputation (or completer analysis only) not specified |
Selective reporting (reporting bias) | Low risk | All outcomes described in Methods section are reported in Results section |
Other bias | Unclear risk | Small sample size |