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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 3-arm parallel group design.
Participants Setting: Thailand - hospital.
135 women. 37 to 42 weeks’ gestation, cx ≥ 3 cm, inactive labour and requiring analgesia Parity: not reported.
Interventions Experimental: IM tramadol 100 mg (N = 45); IM morphine 100 mg (N = 45). Control: IM pethidine 100 mg (N = 45). Second injection possible after 1 hr of half original study dose, each participant could receive maximum of 2 doses
Outcomes Maternal outcomes: pain severity/relief 30 min, 1, 2, 3, and 4 hrs (rated good, satisfactory, no response), drowsiness, nausea, vomiting. Neonatal outcomes: Apgar at 1 and 5 min, neonatal resuscitation
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported.
Allocation concealment (selection bias) Unclear risk Not reported.
Blinding (performance bias and detection bias)
Women
Unclear risk States blind but does not describe the method.
Blinding (performance bias and detection bias)
Clinical staff
Unclear risk States blind but does not describe the method.
Blinding (performance bias and detection bias)
Outcome assessor
Low risk Medical students unaware of group allocation assessed outcome
Incomplete outcome data (attrition bias)
All outcomes
Low risk All participants analysed.
Selective reporting (reporting bias) Unclear risk Unclear.
Other bias Low risk Age and maternal weight balanced at baseline.