El‐Radaideh 2007.
Methods | Double‐blind randomized controlled trial | |
Participants | Age (years, mean ± SD): Group P = 47.9 ± 13.8, Group L = 48.7 ± 13.7, Group LF = 46.0 ± 14.2, Group R = 44.5 ± 13.4 Gender (M:F): Group P = 23:27, Group L = 21:29, Group LF = 18:32, Group R = 24:26 Inclusion criteria: age 21 years to 73 years old, ASA I‐III, elective gynaecological, urological or general surgical procedures Exclusion criteria: refusal of consent, heart failure, renal failure and liver dysfunction. Patients taking sedatives, analgesics, central nervous system (CNS) depressants or anti‐seizure medication, or with a history of intolerance or adverse reactions to the medications used in the study Recruitment: 200 adult patients randomly assigned (50 in each group) Setting: Jordan |
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Interventions |
Pretreatment with venous occlusion A total of 200 patients (50 patients each group) were randomized by a sealed envelope system to be pretreated with either 4 ml lidocaine 1% (40 mg) (Group L) 2 ml lidocaine 2% (40 mg) mixed with 2 ml fentanyl (100 mcg) (Group LF) 4 ml IV paracetamol 40 mg (Group R) 4 ml isotonic sodium chloride solution as placebo (Group P) followed by propofol 2.5 mg/kg after 60 seconds of venous occlusion. |
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Outcomes | Pain intensity assessed on 2‐point scale 0 = no pain 1 = any 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 | "A total of 200 patients (50 patients each group) were randomized by a sealed envelope system." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | N/A |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The anaesthesiologist, who was blind to the content of the study syringe, assessed the pain on injection associated with propofol." |
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. |