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. 2016 Feb 18;2016(2):CD007874. doi: 10.1002/14651858.CD007874.pub2

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
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
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
  1. Incidence of high‐intensity pain

  2. Incidence of pain

  3. Adverse effects


Outcomes sought but not reported
  1. Patient satisfaction

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