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

Crisp 2012.

Study characteristics
Methods Parallel, participants received IV opioids on postoperative day 0 only, with follow‐up to 14 days
Participants PCA 32, control 27
Vaginal reconstructive surgery
Interventions PCA: hydromorphone. Bolus/lockout/4 h limit: 0.2 mg/8 min/5 mg
Control: IV hydromorphone 0.5 mg every 2 h with option to decline
Outcomes Primary: pain intensity and satisfaction with pain control
Secondary: opioid use, side effects
Source of funding Not mentioned
Notes QS = 3 (R = 2, DB = 0, W = 1)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated (nQuery Advisor) randomization table
Allocation concealment (selection bias) Low risk Sequentially numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes High risk Not mentioned – assume no blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk Low numbers of dropouts, not related to interventions
Selective reporting (reporting bias) Low risk Trial registered on clinicaltrials.gov NCT01442818. No results posted, but amount of opioid used not listed as secondary outcome. Primary outcomes same as in manuscript
Other bias Unclear risk Small sample size