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. Author manuscript; available in PMC: 2014 Nov 16.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007396. doi: 10.1002/14651858.CD007396.pub2
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.
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
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