Pettersson 2000.
| Study characteristics | ||
| Methods | Parallel, study terminated on morning of third postoperative day | |
| Participants | PCA 25, IV 25 Coronary artery bypass graft | |
| Interventions | PCA: ketobemidone. Bolus/lockout/4 h limit: 1 mg/6 min/30 mg (adjustment permitted, same settings in both ICU and ward) Control: IV ketobemidone. ICU: nurse controlled infusion, adjusted according to nurse assessment of need (dose range not specified); ward: 2 mg to 5 mg prn patient request or VAS > 3 Both groups also received acetaminophen 1 g every 6 h |
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| Outcomes | Pain intensity on coughing/deep breathing, opioid consumption, patient and nurse satisfaction, LOS, side effects (nausea/vomiting, respiratory rate < 10 or > 20 breaths per minute, degree of sedation) | |
| Source of funding | Supported, in part, by a grant from The Karolinska Institute, Stockholm, Sweden | |
| Notes | No somnolence or arterial desaturation
Withdrawals (1 from each group): incomplete protocol (n = 1), minor neurological deficit (n = 1) (group for each not specified, not included in analyses) QS = 3 (R = 2, DB = 0, W = 1) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Group assignment was achieved by placing instructions for one of the two analgesia alternatives in each of 50 envelopes. The envelopes were sealed, thoroughly mixed, and assigned a number from 1 to 50. Each participating patient was consecutively assigned an envelope number and ketobemidone was administered according to the instructions in the envelope." |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| 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 | Low number of dropouts, equally distributed between groups and apparently unrelated to interventions |
| Selective reporting (reporting bias) | Low risk | All outcomes described in Methods section are reported in Results section. LOS reported despite not being listed in Methods |
| Other bias | Unclear risk | Small mple size |