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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: South Africa - hospital.
75 women. Healthy with no clinically detectable abnormality, in active labour, spontaneous and induced, and requiring analgesia. Excluded if history of hypersensitivity to any drug, previous caesarean, preterm labour, cardiac, pulmonary or renal disease and significant hypertension
Parity: mixed.
Interventions Experimental: IM meptazinol 100 mg (N = 37).
Control: IM pethidine 100 mg (N = 38).
No concomitant analgesia given, metoclopramide 10 mg as required for nausea
Outcomes Maternal outcomes: pain at 1 hr 5-point VAS scale, drug-related side effects. Neonatal outcomes: Apgar at 1 and 5 min, paediatrician assessment at 24 hours
Notes
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 does not describe how blinding achieved
Blinding (performance bias and detection bias)
Clinical staff
Unclear risk States double blind but does not describe how blinding achieved
Blinding (performance bias and detection bias)
Outcome assessor
Unclear risk States double blind but does not describe how blinding achieved
Incomplete outcome data (attrition bias)
All outcomes
High risk Number of women randomised not reported only number analysed, not same numbers analysed for all outcomes
Selective reporting (reporting bias) Unclear risk Unclear.
Other bias Unclear risk Women requiring caesarean or epidural were excluded from further study, unclear if this is pre- or post-randomisation