Methods | RCT, 2-arm parallel groups. | |
Participants | Hospital setting. 199 women: in labour, at term gestation, following normal pregnancy No inclusion or exclusion criteria reported. |
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Interventions | Experimental: IM pentazocine 20-40 mg (N = 91). Control: IM pethidine 50-100mg(N= 89). |
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Outcomes | Primary: analgesic and sedative effects. Pain assessed at time of birth or when second injection administered, as very good, good, moderate or none Secondary: maternal and neonatal side effects. |
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Notes | If additional analgesia required opioid repeated once after 3 or > hrs of first injection. Actual dose received by women not reported | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | Ampoules numbered and in random order. |
Blinding (performance bias and detection bias) Women |
Unclear risk | Reported as double blind, but no description of how achieved. Identical volume but appearance not described |
Blinding (performance bias and detection bias) Clinical staff |
Unclear risk | Reported as double blind, but no description of how achieved. Identical volume but appearance not described |
Blinding (performance bias and detection bias) Outcome assessor |
Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | All participants analysed, but missing data for some outcomes |
Selective reporting (reporting bias) | Unclear risk | Unclear. |
Other bias | Low risk | Balanced at baseline for age, parity, blood pressure, pulse, frequency contractions, FHR, augmented labour, intensity of labour, membranes intact or ruptured |