Amireh 2009.
Methods |
Design: double‐blind, prospective randomized controlled trial Country: Jordan Multisite: no International: no Treatment timing: preoperative period Follow‐up: 24 hours postoperatively Operative procedure(s): laparoscopic cholecystectomy Randomization unit: participants Analysis unit: individual |
|
Participants |
Screened participants were excluded if:
Randomized to:
Main characteristics of participants:
|
|
Interventions |
Co‐interventions: none stated |
|
Outcomes |
Primary outcomes:
These 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:
|
|
Notes | Trial registration: not found Funder: none stated A priori sample size estimation: not stated Conducted: August 2003 to May 2004 Declared conflicts of interest: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were prospectively and randomly divided into 2 groups. |
Allocation concealment (selection bias) | Low risk | Randomization was performed by the nurse in the preoperative holding area who picked 1 of a prearranged and sealed 60 similar envelopes.= |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The participant, the anaesthesia provider, the postoperative study investigator, and the nurses in recovery area and on the wards were unaware of the participants's group. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The participant, the anaesthesia provider, the postoperative study investigator, and the nurses in recovery area and on the wards were unaware of the participant's group. |
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. |