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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: UK hospital.
94 women. > 35 weeks’ gestation, age ≥ 18 years, excluded if diabetic, history of renal or hepatic impairment or taking monoamine oxidase inhibitors, in active labour and requiring analgesia
Parity: ≤ 3.
Interventions Experimental: IM pentazocine 60 ≤ mg (N = 46).
Control: IM pethidine 15 ≤ 0 mg (N = 48).
Up to 3 injections > 3 hours apart at maternal request.
Outcomes Maternal outcomes: satisfied with analgesia, nausea, vomiting, sleepiness, use of additional analgesia (study drug), method of birth. Neonatal outcomes: Apgar at 1 and 5 min
Notes Data for some outcomes available after first dose.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported.
Allocation concealment (selection bias) Unclear risk Not reported.
Blinding (performance bias and detection bias)
Women
Unclear risk States double blind but how achieved not reported.
Blinding (performance bias and detection bias)
Clinical staff
Unclear risk States double blind but how achieved not reported.
Blinding (performance bias and detection bias)
Outcome assessor
Unclear risk States double blind but how achieved not reported.
Incomplete outcome data (attrition bias)
All outcomes
High risk Exclusions from most analyses.
Selective reporting (reporting bias) Unclear risk Unclear.
Other bias Low risk Balanced at baseline for age, parity, induced labour onset.