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. |
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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 |
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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 |