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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 Italy: hospital care setting.
40 women. Full-term pregnancy, cx ≥ 4 cm, in spontaneous active labour and requiring analgesia
Interventions Experimental: IM tramadol 100 mg (N = 20).
Control: IM pethidine 75 mg (N = 20).
Outcomes Primary outcome: maternal pain relief and acceptability. Pain assessed hrly up to 5 hrs, VAS 1-3
Secondary outcomes: maternal: observations (pulse, BP, respiratory rate, arterial oxygen saturation). Neonatal: Apgar at 1 and 5 min. Umbilcal cord pH
Notes Second dose of study drug allowed after 2 hrs as required. Italian language, translation obtained. Data were presented in a way in which we were not able to incorporate them into data tables in RevMan
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated.
Allocation concealment (selection bias) Unclear risk Not reported.
Blinding (performance bias and detection bias)
Women
Unclear risk Not reported.
Blinding (performance bias and detection bias)
Clinical staff
Unclear risk Not reported.
Blinding (performance bias and detection bias)
Outcome assessor
Unclear risk Not reported.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk Unclear how many women analysed as only percentages reported
Selective reporting (reporting bias) Unclear risk Unclear.
Other bias High risk No baseline characteristics table - unclear re maternal parity
Likely response bias as no information on whom women reported to about their pain post injection