Sethi 2009.
Methods | Double‐blind randomized controlled trial | |
Participants | Age (years, mean ± SD): Group A = 42.02 ± 14.12, Group B = 40.63 ± 13.71, Group C = 41.5 ± 14.63 Gender (M:F): Group A = 59:41, Group B = 61:39, Group C = 49:51 Inclusion criteria: age 18 years to 65 years old, ASA I‐III, elective surgery Exclusion criteria: patients with ischaemic heart disease and neurological problems, pregnant or lactating patients, those who were taking any analgesics before surgery, or those with known hypersensitivity to propofol or to any of the constituents of the emulsion (soy‐bean oil, MCT, glycerol, egg lecithin, sodium oleate or water for injection) Recruitment: 300 adult patients were randomly assigned (100 in each group) Setting: India |
|
Interventions |
Admixture The patients were assigned to 3 groups (100 each), using computer generated randomization Group A received propofol‐MCT/LCT premixed with normal saline (1 ml of normal saline added to 19 ml propofol‐lipuro) Group B received propofol‐MCT/LCT premixed with lidocaine (1 ml of 2% lidocaine added to 19 ml propofol‐lipuro) Group C received propofol‐LCT premixed with lidocaine (1 ml of 2% lidocaine added to 19 ml propofol) The investigators and patients were blinded to the study preparation being used |
|
Outcomes | Pain intensity assessed on 4‐point scale 0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain or grimacing, or both, or withdrawal of limb Outcomes reported and used
Outcomes sought but not reported
|
|
Notes | Period of the study: dates not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Using computer‐generated randomization |
Allocation concealment (selection bias) | Unclear risk | N/A |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No data about blind methods for personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The investigators and patients were blinded to the study preparation being used." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | N/A but assuming from the table all patients were included |
Selective reporting (reporting bias) | Unclear risk | N/A |
Other bias | Low risk | The study appears to be free of other sources of bias |