Ali 2003.
Methods |
Design: double‐blind, prospective randomized controlled trial Country: USA Multisite: no International: no Treatment timing: preoperative period Follow‐up: 24 hours postoperatively Operative procedure(s): laparoscopic or gynaecological surgery Randomization unit: participants Analysis unit: individual |
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Participants |
Screened participants were excluded if they:
Randomized to:
No withdrawals were stated. Main characteristics of participants:
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Interventions |
Co‐interventions: none stated |
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Outcomes |
Primary outcomes:
Outcomes were reported in the following time periods: 0 to 1 hour, 1 to 24 hours, and 0 to 24 hours postoperatively Secondary outcomes included:
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Notes | Trial registration: not found Funder: none stated A priori sample size estimation: stated on page 782 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 based on computer‐generated codes that were maintained in sequentially numbered, opaque envelopes. |
Allocation concealment (selection bias) | Unclear risk | Randomization was based on computer‐generated codes that were maintained in sequentially numbered, opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The anaesthesia provider, the postoperative study investigator, and the PACU nurses were blinded to allocation of the groups, as were the participants. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The anaesthesia provider, the postoperative study investigator and the PACU nurses were blinded to allocation of the groups, as were the participants. |
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 | Low risk | There were no other sources of bias. |