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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 Stockholm Sweden, hospital setting.
20 healthy nulliparous women in active labour after spontaneous rupture of the membranes, cephalic presentation. No exclusion criteria specified
Interventions Experimental: 0.05 mg/kg IV morphine up to 3 doses (max 0.15 mg/kg body weight)
Control: 0.5 mg/kg IV pethidine up to 3 doses (max 1.5 mg/kg body weight) Both groups had continuous FHR monitoring.
Outcomes Sedation rates; CS, nausea and vomiting.
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk “assigned at random.”
Allocation concealment (selection bias) Low risk Coded ampoules provided by pharmacy.
Blinding (performance bias and detection bias)
Women
Low risk Described as double blind; pharmacy provided identical coded ampoules
Blinding (performance bias and detection bias)
Clinical staff
Low risk Described as double blind; pharmacy provided identical coded ampoules
Blinding (performance bias and detection bias)
Outcome assessor
Unclear risk Unclear.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No apparent loss to follow-up.
Selective reporting (reporting bias) Unclear risk Unclear.
Other bias Unclear risk Small sample and no clear information that groups were comparable at baseline. Range of cervical dilations at recruitment between 4 and 9 cm