Onyando 2014.
Methods | Design: double‐blind, prospective randomized controlled trial Country: Kenya Multisite: no International: no Treatment duration: preoperative period Follow‐up: 24 hours postoperatively Operative procedure(s): gynaecological surgery Randomization unit: participants Analysis unit: individual | |
Participants |
Exclusion criteria included:
Randomized to:
Main characteristics of participants:
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Interventions |
Co‐interventions: none stated |
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Outcomes |
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Notes | Trial registration: not stated Funder: not stated A priori sample size estimation: stated on page 13 Conducted: dates not stated Declared conflicts of interest: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was completed using a computer‐generated table of random numbers. |
Allocation concealment (selection bias) | Unclear risk | Randomization was completed using a computer‐generated table of random numbers. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study participants, the anaesthetist, PACU nurses, and post‐surgical ward nurses were unaware of the group assignments. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Postoperative care nurses documented outcomes and were blinded to group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals were stated. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | Unclear risk | The duration of anaesthesia was significantly shorter for the experimental group. |