Han 2010.
Methods | Double‐blind randomized controlled trial | |
Participants | Age (years, mean ± SD): Group 1 = 47 ± 14.5, Group 2 = 51 ± 13.5, Group 3 = 50 ± 14.4 Gender (M:F): Group 1 = 20:20, Group 2 = 20:20, Group 3 = 19:21 Inclusion criteria: age 20 years to 65 years old, ASA I‐II, elective surgery Exclusion criteria: patients with self‐confirming allergies to opioids, local anaesthetics, asthma, neurological deficits and those who had received analgesics or sedatives within the previous 24 hours Recruitment: 120 adult patients randomly assigned (40 in each group) Setting: Korea |
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Interventions |
Admixture Patients were allocated randomly into one of three groups (n = 40, in each) The patients in the remifentanil group (Group 1) received remifentanil 0.5 mcg/kg IV pretreated for 30 seconds before a micro emulsion propofol injection The patients in the lidocaine group (Group 2) received propofol 2 mg/kg premixed with 40 mg lidocaine over a 60 second period. The patients in the combination group (Group 3) received both remifentanil and lidocaine |
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Outcomes | Pain intensity assessed on 4‐point scale 0 = no pain 1 = mild pain (a minor verbal/facial response or motor reaction to the injection) 2 = moderate pain (a clear verbal/facial response or motor reaction to the injection) 3 = severe pain (the patient both complained of pain and withdrew their arm) Outcomes reported and used
Outcomes sought but not reported
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Notes | Period of the study: dates not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The patients were allocated randomly to one of three groups using a computer generated randomization list manipulated by a statistician in a sealed envelope." |
Allocation concealment (selection bias) | Unclear risk | N/A |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The patients, anaesthesia providers and investigators who scored the movements were blinded to the treatment group." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The patients, anaesthesia providers and investigators who scored the movements were blinded to the treatment group." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | Unclear risk | N/A |
Other bias | Low risk | The study appears to be free of other sources of bias |