McCluskey 2003.
Methods | Randomized controlled trial | |
Participants | Age (years, mean ± SD): Control group = 36.7 ± 11.3, EMLA group = 37.1 ± 11.2, Lidocaine group = 41.4 ± 10.7 Gender (M:F): 100% female Inclusion criteria: Age 18 years to70 years old, ASA I‐II, gynaecological day case‐surgery Exclusion criteria: N/A Recruitment: 90 adult patients randomly assigned (30 in each group) Setting: United Kingdom |
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Interventions |
Admixture Control group: placebo cream applied over a wide area to the dorsum of the nondominant hand and distal forearm 60 min before surgery and anaesthesia induced with 18 ml of 1% propofol (Diprivan®) mixed with 2 ml of 0.9% saline EMLA group: EMLA cream applied as described above and anaesthesia induced with 18 ml of 1% propofol mixed with 2 ml of 0.9% saline Lidocaine group: placebo cream applied as described above and anaesthesia induced with 18 ml of 1% propofol premixed with 2 ml of 2% lidocaine (40 mg). |
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Outcomes | Pain intensity assessed on 4‐point scale 0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain 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) | Unclear risk | N/A |
Allocation concealment (selection bias) | Low risk | "The patients were randomly allocated by sealed envelope into three groups." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | N/A |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "The nurses who insert IV cannula were the investigator assessing pain on propofol injection". Possible bias as nurses might suspect patient had had EMLA if they did not have pain when IV cannula inserted. However, the nurses would not know whether patient was in control or lidocaine group which were the groups whose results we analysed. |
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 |