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. Author manuscript; available in PMC: 2014 Nov 16.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007396. doi: 10.1002/14651858.CD007396.pub2
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.