Methods | RCT, 2-arm parallel group design. | |
Participants | Setting: hospital in Surrey, UK. 17 healthy women 36-40 weeks’ gestation requesting pethidine for pain relief in labour, ASA I or II. Women with a contraindication to pethidine or remifentanil or requesting epidural were excluded |
|
Interventions | Experimental: IV PCA remifentanil, 0.5 mcg bolus per kg (based on antenatal booking weight) with 2 min lock-out, no hourly max Control: IV PCA pethidine, 10 mg bolus, 5 min lock-out, 100 mg hourly max All women were given 10 mg metoclopramide IV over 8 hrs. |
|
Outcomes | Maternal: pain on 10 cm VAS recorded hourly; nausea recorded on a 10 cm VAS; itching; BP pulse and resps Neonate: 1 and 5 min Apgar scores. |
|
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described “randomly allocated”. |
Allocation concealment (selection bias) | Low risk | “by selecting the next in a series of sealed envelopes prepared by pharmacy.” |
Blinding (performance bias and detection bias) Women |
Low risk | Women were described as blind. |
Blinding (performance bias and detection bias) Clinical staff |
Unclear risk | “One investigator selected the envelope and prepared the PCA pump. the pump was covered so that the other investigator, the observer, was unable to see which drug the woman was receiving.” |
Blinding (performance bias and detection bias) Outcome assessor |
Unclear risk | See above. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | No loss to follow-up apparent although for some outcomes it was not clear what the denominators were |
Selective reporting (reporting bias) | Unclear risk | Unclear. |
Other bias | Low risk | None apparent. |