Aldrete 2010.
Methods | A comparative, double‐blind randomized controlled trial | |
Participants | Age: N/A Gender: N/A Inclusion criteria: N/A Exclusion criteria: N/A Recruitment: 22 adult patients undergoing pain relief procedures Setting: USA |
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Interventions |
Admixture Propofol 1.7 mg/kg from Baxter Laboratories, premixed with either 5 ml of 2% lidocaine or 5 ml of NaCl 0.9%, was compared with propofol Laboratorios Dr Gray, which was similarly mixed. Baxter premixed with 2% lidocaine 5 ml Baxter premixed with NSS 5 ml Gray premixed with 2% lidocaine 5 ml Gray premixed with NSS 5 ml 16 injections were randomly administered four times each, blindly, to each of 22 patients (total 352 injections). |
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Outcomes | Pain intensity assessed on 4‐point scale 0 = None 1 = Verbal complaint 2 = Moved arm 3 = Moved body (Moved arms or body was considered as moderate to severe 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) | Unclear risk | N/A |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The patients and the physician (J. A. A.) were blinded as to what preparation of propofol was to be administered at each treatment." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "Evaluation of the pain response and related events were recorded by a trained observer (F. H. M.)." (but N/A about blinding) |
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 | High risk | Jose Alcover is the chief pharmacist at ‘Laboratories Dr Gray’. The Propofol used for this study was donated by ‘Laboratories Dr Gray’ to the senior author (J. A. A.) |