Aouad 2007.
Methods | Prospective, double‐blind randomized controlled trial | |
Participants | Age (years, mean ± SD): Group I = 37.9 ± 12.4, Group II = 38.8 ± 15.1, Group III = 36.7 ± 13.7 Gender (M:F): Group I = 24:30, Group II = 18:32, Group III = 24:28 Inclusion criteria: ASA I‐III, elective surgery Exclusion criteria: indication for rapid sequence induction of anaesthesia, known allergy to any of the study drugs, ASA physical status IV, haemodynamic instability, psychiatric disorders, severe neurological deficits, and patients receiving opioids as long‐term treatment Recruitment: 156 adult patients were randomly assigned. Setting: Lebanon |
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Interventions |
Admixture Participants in the lidocaine group (Group I) (n = 54) received 2% lidocaine premixed with propofol (40 mg lidocaine in 180 mg propofol). Participants in the remifentanil group (Group II) (n = 50), received pretreatment with remifentanil 2 mcg/kg IV over 30 sec. Participants in the combination group (Group III) (n= 52) received both lidocaine premixed with propofol and pretreatment with remifentanil |
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Outcomes | Pain intensity assessed on 4‐point scale 1 = no pain 2 = mild pain, if only report after questioning patient 3 = moderate pain, if spontaneous verbal expression of pain without grimacing or withdrawal of arm occurred 4 = severe pain, if spontaneous strong vocal response with facial grimacing or withdrawal of arm occurred during the injection of propofol 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 | "The patients were randomly assigned according to a computer‐generated random table to one of three groups." |
Allocation concealment (selection bias) | Unclear risk | N/A |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "All the syringes used were prepared by the resident and their identity was concealed." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The incidence and severity of pain were assessed during the injection of the study dose of propofol by an anaesthesiologist who was blinded to the group to which the patient was assigned." |
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. |