Methods | RCT 2-arm parallel group design. | |
Participants | Setting: UK hospital. 1,100 women. 37-42 weeks’ gestation, in active labour and requiring analgesia Parity: 44% primips, 56% multips. |
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Interventions | Experimental: IM meptazinol 100 mg ≤ 70 kg, 150 mg > 70 kg (N = 513) Control: IM pethidine 1100 mg ≤ 70 kg, 150 mg > 70 kg (N = 522) Second dose, epidural or inhalation analgesia at maternal request |
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Outcomes | Maternal outcomes: maternal pain at 30, 60, 90 and 120 minutes VAS (0-100 mm), nausea, vomiting, sleepiness, use of supplementary analgesia, method of birth, opinion of analgesic effect assessed 3-5 days postpartum (rated excellent, good, poor but just able to cope, no effect and required additional analgesia). Neonatal outcomes: Apgar at 1 and 5 min, resuscitation, naloxone administration, fetal distress, type of feeding | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Low risk | Coded drug containers prepared at a site remote from the trial |
Blinding (performance bias and detection bias) Women |
Low risk | States double blind and used coded drug containers. |
Blinding (performance bias and detection bias) Clinical staff |
Low risk | States double blind and used coded drug containers. |
Blinding (performance bias and detection bias) Outcome assessor |
Low risk | States double blind and used coded drug containers. |
Incomplete outcome data (attrition bias) All outcomes |
High risk | 65 women excluded due to clerical errors or administration of wrong drug |
Selective reporting (reporting bias) | Unclear risk | Unclear. |
Other bias | Unclear risk | Women were balanced at baseline for age, weight, parity and gestation |