Methods | RCT, 2-arm parallel group design. | |
Participants | Setting: Washington, USA. 194 women in established labour. Analgesia was given at approximately 4-5 cm cervical dilatation |
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Interventions | Experimental: IV phenazocine 1 mg. Control: IV pethidine 50 mg. Both groups received promethazine 50 mg, and for both groups “birth was accomplished under pudendal nerve block anaesthesia with terminal self-administered trichloroethylene” |
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Outcomes | Pain relief (recorded by women on the first postpartum day); nausea and vomiting; adverse effects; progress in labour; Apgar scores at 1 and 5 mins | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Low risk | Drugs were prepared by pharmacy in identical coded vials and the code was not broken by the pharmacist until the study had been completed |
Blinding (performance bias and detection bias) Women |
Low risk | Drugs in identical vials. |
Blinding (performance bias and detection bias) Clinical staff |
Low risk | Pharmacy prepared identical coded drugs. |
Blinding (performance bias and detection bias) Outcome assessor |
Unclear risk | Unclear. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Missing data for some outcomes (approximately 5% for maternal postpartum outcomes, and 10% for nurse recorded evaluations in labour) |
Selective reporting (reporting bias) | Low risk | None apparent. |
Other bias | Low risk | None apparent. |