Wasiak 2011.
| Methods | Randomised, double‐blind, placebo‐controlled cross‐over study. Allocation concealment stated; method of randomisation stated; participants, staff and outcome assessors blind to treatment assignment and medication administration | |
| Participants | 45 participants with burns (mean % total body surface area 12.96%, range 3% to 55%) undergoing wound care procedures (i.e. dressing changes or debridement, or both) on 2 consecutive days following split skin‐graft surgery. Participants aged 16‐68 years | |
| Interventions | Intervention: lidocaine dose of 1.5 mg/kg/body weight followed by 2 boluses of 0.5 mg/kg at 5‐minute intervals followed by a continuous infusion Control: 0.9% sodium chloride administered at an equivalent volume, dose and rate to that of lidocaine |
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| Outcomes | Verbal rating scale scores measured before, during and after the procedure; time to rescue analgesia; opioid requests and consumption using patient‐controlled analgesia; overall participant anxiety and level of satisfaction | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "subjects were randomized to one of two treatment sequence groups i.e. treatment A or treatment B, using block randomization" |
| Allocation concealment (selection bias) | Low risk | Quote: "Allocation of treatment regime was done using the opaque sealed envelope technique, in which envelopes with cards detailing which treatment regime were allocated to patients on the morning of each dressing" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Subjects, staff and researchers were blinded to treatment assignments with all study medications identical in appearance. During the infusion, research staff administering the study medication was blind to the outcome assessments and the patient and research assistant were blinded to the study medication administration" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The authors did not report any loss to follow‐up participants for the primary outcome measures |
| Selective reporting (reporting bias) | Unclear risk | Authors did not provide overall participant satisfaction and anxiety scores |
| Size | High risk | < 50 participants per treatment arm |
| Other bias | Unclear risk | Not stated |