Behdad 2011.
Methods |
Design: double‐blind, prospective randomized controlled trial Country: Iran Multisite: no International: no Treatment timing: intraoperative period Follow‐up: 24 hours postoperatively Operative procedure(s): tympanomastoidectomy Randomization unit: participants Analysis unit: individual |
|
Participants |
Screened participants were excluded:
Randomized to:
Main characteristics of participants:
|
|
Interventions |
Co‐interventions: none stated |
|
Outcomes |
These outcomes were all measured in the recovery room until discharge from the recovery room. |
|
Notes | Trial registration: not stated Funder: not stated A priori sample size estimation: stated Conducted: summer 2009 Declared conflicts of interest: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Paper states participants were (quote) "randomly allocated" but does not explain further. |
Allocation concealment (selection bias) | Unclear risk | Paper states participants were (quote) "randomly allocated" but does not explain further. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | It is stated that the study is (quote) "double‐blind", but it is not clear that the surgical care team was blinded to the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study personnel measuring outcomes were not aware of 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 | Low risk | There were no other sources of bias. |