Methods | RCT, 2-arm parallel group design. | |
Participants | Setting not clear (hospital in USA). 100 women in good health in active labour, with no addiction to or tolerance to drugs and complaining of moderate to severe pain. Women who “planned to nurse” were excluded |
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Interventions | Experimental: (50 women) IV butorphanol 1-2 mg (44 women had an initial dose of 1 mg and 6 an initial dose of 2 mg, after one hr or more a 2nd dose was given if requested) Control: (50 women) IV pethidine 40-80 mg (45 women had an initial dose of 40 mg and 5 an initial dose of 80 mg, a 2nd dose was given after 1hr or more if requested) | |
Outcomes | Pain (5-point scale 0 - no pain, 4 - very severe pain); pain relief (5-point scale 0 - none, 4 - complete relief); FHR; Apgar scores at 1 and 5 minutes | |
Notes | ||
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 described. |
Blinding (performance bias and detection bias) Women |
Unclear risk | Described as double blind study but no details provided. |
Blinding (performance bias and detection bias) Clinical staff |
Unclear risk | Unclear. |
Blinding (performance bias and detection bias) Outcome assessor |
Unclear risk | Unclear. |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | Outcome data were available for all women randomised. |
Selective reporting (reporting bias) | Unclear risk | Unclear. |
Other bias | Unclear risk | No baseline imbalance was apparent although 8 women in the butorphanol group were induced compared with 1 woman in the pethidine group |