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. 2015 Jun 2;2015(6):CD003348. doi: 10.1002/14651858.CD003348.pub3

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)
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)
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