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. Author manuscript; available in PMC: 2014 Nov 16.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007396. doi: 10.1002/14651858.CD007396.pub2
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
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