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

Reddy 2001.

Methods Double‐blind randomized controlled trial
Participants Age (years, mean ± SD): Group 1 = 33.5 ± 13.5, Group 2 = 39.8 ± 14.2, Group 3 = 41.4 ± 18.3
Gender (M:F): Group 1 = 12:8, Group 2 = 9:11, Group 3 = 10:10
Inclusion criteria: ASA I‐II, elective orthopaedic and gastrointestinal procedures
Exclusion criteria: N/A
Recruitment: 60 adult patients randomly assigned (20 in each group)
Setting: Singapore
Interventions Pretreatment with venous occlusion
Group 1 received 5 ml 0.9% sodium chloride solution intravenously as the control
Group 2 received ondansetron 4 mg (2 mg/ml) diluted with water into a 5‐ml solution
Group 3 received 50 mg lidocaine (5 ml of 1% solution) intravenously
Outcomes Pain intensity assessed on 4‐point scale
0 = no pain
1 = mild pain (pain in response to questioning only without any behavioural signs)
2 = moderate pain (pain in response to questioning and accompanied by behavioural sign or pain reported spontaneously without questioning)
3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears)
Outcomes reported and used
  1. Incidence of high‐intensity pain

  2. Incidence of pain


Outcomes sought but not reported
  1. Adverse effects

  2. Patient satisfaction

Notes Period of the study: dates not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Subjects were randomly allocated to one of three groups by the drawing of lots."
Allocation concealment (selection bias) Unclear risk N/A
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "All syringes of test solution were prepared by another investigator and covered so that
the investigator who assessed the patient's response was unaware of the nature of the solution."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "All syringes of test solution were prepared by another investigator and covered so that the investigator who assessed the patient's response was unaware of the nature of the solution."
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