Methods | RCT 2-arm parallel group design. | |
Participants | Setting: UK hospital. 94 women. > 35 weeks’ gestation, age ≥ 18 years, excluded if diabetic, history of renal or hepatic impairment or taking monoamine oxidase inhibitors, in active labour and requiring analgesia Parity: ≤ 3. |
|
Interventions | Experimental: IM pentazocine 60 ≤ mg (N = 46). Control: IM pethidine 15 ≤ 0 mg (N = 48). Up to 3 injections > 3 hours apart at maternal request. |
|
Outcomes | Maternal outcomes: satisfied with analgesia, nausea, vomiting, sleepiness, use of additional analgesia (study drug), method of birth. Neonatal outcomes: Apgar at 1 and 5 min | |
Notes | Data for some outcomes available after first dose. | |
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 double blind but how achieved not reported. |
Blinding (performance bias and detection bias) Clinical staff |
Unclear risk | States double blind but how achieved not reported. |
Blinding (performance bias and detection bias) Outcome assessor |
Unclear risk | States double blind but how achieved not reported. |
Incomplete outcome data (attrition bias) All outcomes |
High risk | Exclusions from most analyses. |
Selective reporting (reporting bias) | Unclear risk | Unclear. |
Other bias | Low risk | Balanced at baseline for age, parity, induced labour onset. |