Methods | RCT, 3-arm parallel groups. | |
Participants | Setting: The Netherlands, Department of Obstetrics and Gynaecology 180 enrolled, 159 completed the study. Inclusion criteria: healthy ASA physical status I or II term parturients in an active stage of labour, with singleton cephalic presentation, without prior administration of opioid analgesics Exclusion criteria: obesity (BMI ≥ 40 kg m−2), opioid allergy, substance abuse history, and high-risk patients (pre-eclampsia, severe asthma, insulin-dependent diabetes mellitus, hepatic insufficiency, or renal failure) |
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Interventions |
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Outcomes | Outcomes: pain scores (VAS) every hour; sedation score (1 awake, 2 sleepy, 3 eyes closed, 4 eyes closed but rousable, 5 unrousable; overall satisfaction on 10-point scale 2 hours after delivery; side effects - nausea, vomiting, itching; Apgar scores at 1, 5 mins; cord blood gas analysis; NACS scores at 15 min and 2 hr after delivery; oxytocin use; instrumental delivery; CS; spontaneous delivery | |
Notes | “All women received similar instructions on how to use the PCA device: all parturients were instructed to press the bolus button whenever they needed pain relief.” | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Established using a computer generated random sequence in numbered envelopes.” |
Allocation concealment (selection bias) | Low risk | “Study medication was prepared and blinded by hospital pharmacy.” |
Blinding (performance bias and detection bias) Women |
Unclear risk | Not reported. |
Blinding (performance bias and detection bias) Clinical staff |
Low risk | “Observants and medical personnel attending to the parturient were unaware of the drug assignment.” |
Blinding (performance bias and detection bias) Outcome assessor |
Low risk | “with exception of baseline data, all observations and measurements were made by blinded observers.” |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | 180 enrolled, 159 completed the study: 52 R group; 53 M group; 54 F group; 21 excluded because delivered within 1 hour after randomisation Says “Data analysis was per-protocol”. |
Selective reporting (reporting bias) | Unclear risk | All outcomes discussed in methods appear to have been reported upon within results. However, the study protocol was not evaluated |
Other bias | Low risk | Baseline characteristics similar. |