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

Paoletti 1993 (gyn).

Study characteristics
Methods Parallel, 48 h
Participants PCA 22, control 22
Gynecologic surgery (second study within paper not reported here as control group received continuous infusion not titrated to patient requirements)
Interventions PCA: morphine. Bolus/lockout/4 h limit: 1 mg/6 to 15 min/NR
Control: IM morphine 10 mg every 6 h prn
Outcomes Pain, opioid usage, sedation, respiratory rate, nausea/vomiting, itch, sweating, quality of sleep, patient satisfaction
Source of funding Not mentioned
Notes Withdrawal: PCA, n = 1: hypotension/apnea
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 described
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias)
All outcomes High risk Not explicitly stated, but appears to be unblinded
Incomplete outcome data (attrition bias)
All outcomes Low risk Data reported on all but 1 participant (PCA, withdrew due to AE)
Selective reporting (reporting bias) High risk All outcomes described in Methods section are reported in Results section; however spread for continuous outcomes not reported
Other bias High risk Very small sample size