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. |
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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. |