Apiliogullari 2007.
Methods | Double‐blind randomized controlled trial | |
Participants | Age (years, mean ± SD): Group I = 36.16 ± 10.7, Group II = 35.36 ± 9.6, Group III = 33.46 ± 10.7 Gender (M:F): Group I = 11:49, Group II = 21:39, Group III = 20:40 Inclusion criteria: ASA I or II, elective surgery Exclusion criteria: patients with difficulties in communication or with a history of allergy to diphenhydramine or amide group drugs, diabetes mellitus or cardiac problems and patients who received analgesics or sedative drugs within the 24 hours before surgery Recuitment: 180 adult patients randomly assigned (60 in each group) Setting: Turkey |
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Interventions |
Pretreatment with venous occlusion Group I (placebo) received normal saline 2 ml, Group II received lidocaine 2 ml (40 mg) (Aritmals 2%; Biosel, Istanbul) and Group III received diphenhydramine hydrochloride 2 ml (20 mg) (Benisons; Biosel, Istanbul) A 1 min venous occlusion, followed by propofol into a cephalic forearm vein of the antecubital fossa |
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Outcomes | Pain intensity assessed on 3‐point scale 0 = no pain 1 = mild pain 2 = severe pain (strong vocal response accompanied by facial grimacing, arm withdrawal or tears) 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) | Unclear risk | N/A |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Identical syringes containing study drugs were prepared and labelled by a pharmacist not involved in this study." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "An independent anaesthetist, who was unaware of group assignments, assessed the intensity of the pain the patients experienced." |
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 |