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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 USA: hospital setting.
93 primiparous women in labour, uncomplicated pregnancy at 37 or more weeks’ gestation and in pain described as moderate or severe
Interventions Experimental: IM pentazocine 60 mg (N = 38).
Control: IM pethidine 100 mg (N = 45).
Outcomes Primary: pain relief assessed at 1 hr, as good or poor.
Secondary: maternal side effects, nausea or vomiting, labour progress. Neonatal Apgar score at 1 and 5 min
Notes If additional analgesia was required, a second injection could be administered at the discretion of medic. Not stated if IOL onset included
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported.
Allocation concealment (selection bias) Unclear risk Identical vials with code number but no further information given
Blinding (performance bias and detection bias)
Women
Low risk Identical vials with code number.
Blinding (performance bias and detection bias)
Clinical staff
Low risk Identical vials with code number.
Blinding (performance bias and detection bias)
Outcome assessor
Low risk No-one involved with the immediate care of the woman knew the drug identity
Incomplete outcome data (attrition bias)
All outcomes
High risk 83/93 women analysed and reasons for missing data not reported
Selective reporting (reporting bias) Unclear risk Unclear.
Other bias Unclear risk Unclear how many women randomised to each group and balance at baseline unclear