McKay 2009.
Methods | Randomized, placebo‐controlled trial. No statement on allocation concealment. No statement on blinding of participants, personnel, and outcome assessors. This trial evaluated whether systemic lidocaine would reduce pain and time to discharge in ambulatory surgery patients. The study was conducted in the USA from August 2004 to August 2006. |
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Participants | Number assessed for eligibility: N/A Number randomized: 67 → N/A Number analysed: 29:27 Inclusion criteria Patients 18 to 75 yrs of age (ASA physical status I to III) presenting for outpatient surgery under general anaesthesia. Exclusion criteria N/A Baseline details Experimental group (n = 29) Mean age (years): 43 M = 83%, F = 17% Mean weight (kg): 81 ASA I/II: N/A Duration of anaesthesia (min): N/A Main surgical procedure (n): laparoscopic general (11), open general (3), endocrine and breast (7), laparoscopic gynaecology (4), minor gynaecology (2), urology (0), plastics (2), minor ortho (0), minor ear, nose, throat (0) Control group (n = 27) Mean age (years): 46 M = 78%, F = 22% Mean weight (kg): 81 ASA I/II: N/A Duration of anaesthesia (min): N/A Main surgical procedure (n): laparoscopic general (13), open general (3), endocrine and breast (5), laparoscopic gynaecology (2), minor gynaecology (0), urology (1), plastics (1), minor ortho (1), minor ear, nose, throat (1) |
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Interventions |
Experimental group (29 patients) At induction of anaesthesia, all patients received 1.5 mg/kg of lidocaine by slow IV push. The lidocaine infusion (2 mg/kg/hr) was started immediately after induction of anaesthesia and continued until 1 hr after arrival in the PACU. Control group (27 patients) The control group received saline as placebo. |
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Outcomes | The primary endpoint of the study was time to PACU discharge readiness. Dichotomous
Continuous
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Notes |
Medication "Pain was assessed at rest by a visual analogue scale every 15 min and treated with either fentanyl (0.5 – 1 µg/kg) or morphine (0.01 – 0.02 mg/kg) when pain was more than 3 on a visual analogue scale of 0–10 (0 = no pain, 10 = more pain imaginable). Nausea was assessed at 15‐min intervals and treated with ondansetron or if persistent with promethazine or diphenhydramine." Anaesthesia Anaesthetic management during surgery was standardized for opioid use, ketorolac and prophylaxis for postoperative nausea and/or vomiting. Funding "Supported by departmental funding." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "participants were assigned in a double‐blind 1:1 ratio using a computer‐generated randomization list…" |
Allocation concealment (selection bias) | Unclear risk | No statement on allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "…double‐blind…". No detailed information provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No statement on blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropout rate overall: 16% Quote: "based on an expected withdrawal rate of 20%, 67 patients were enrolled in the trial." Only 56 were analysed, 11 excluded. Excluded patients were not described. |
Selective reporting (reporting bias) | Unclear risk | There is no reference to a trial registry and no published study protocol. |
Other bias | Low risk | The study appears to be free of other sources of bias. |