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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.
100 women in labour at term gestation with uncomplicated pregnancy
Interventions Experimental: Meptazinol 1.8 mg/kg body weight (N = 50).
Control: pethidine 1.8 mg/kg body weight (N = 50).
All participants received promethazine 12.5 mg with first injection
Outcomes Primary: newborn effects: Apgar score at 1 and 3 min.
Notes If additional analgesia required, a repeat injection could be administered 3 hourly 6/50 women from each arm received a second dose at a 3-hourly interval
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 method not described.
Blinding (performance bias and detection bias)
Clinical staff
Unclear risk States double blind but method not described.
Blinding (performance bias and detection bias)
Outcome assessor
Unclear risk States double blind but method not described.
Incomplete outcome data (attrition bias)
All outcomes
High risk 5 babies excluded from analysis due to heart defects and fetal distress
Selective reporting (reporting bias) Unclear risk Unclear.
Other bias Unclear risk Balanced for parity, weight and size of baby at baseline.