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 |
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Interventions | Experimental: IM tramadol 100 mg (N = 20). Control: IM pethidine 75 mg (N = 20). |
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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 |
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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 |