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 |
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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 |
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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
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) | 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 |