Methods | RCT 2-arm parallel group design. | |
Participants | USA: hospital setting. 93 primiparous women in labour, uncomplicated pregnancy at 37 or more weeks’ gestation and in pain described as moderate or severe |
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Interventions | Experimental: IM pentazocine 60 mg (N = 38). Control: IM pethidine 100 mg (N = 45). |
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Outcomes | Primary: pain relief assessed at 1 hr, as good or poor. Secondary: maternal side effects, nausea or vomiting, labour progress. Neonatal Apgar score at 1 and 5 min |
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Notes | If additional analgesia was required, a second injection could be administered at the discretion of medic. Not stated if IOL onset included | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | Identical vials with code number but no further information given |
Blinding (performance bias and detection bias) Women |
Low risk | Identical vials with code number. |
Blinding (performance bias and detection bias) Clinical staff |
Low risk | Identical vials with code number. |
Blinding (performance bias and detection bias) Outcome assessor |
Low risk | No-one involved with the immediate care of the woman knew the drug identity |
Incomplete outcome data (attrition bias) All outcomes |
High risk | 83/93 women analysed and reasons for missing data not reported |
Selective reporting (reporting bias) | Unclear risk | Unclear. |
Other bias | Unclear risk | Unclear how many women randomised to each group and balance at baseline unclear |