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 |
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Outcomes | Primary: pain intensity and satisfaction with pain control Secondary: opioid use, side effects |
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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 |