Blackburn 1995.
| Methods | Single‐centre RCT, emergency department, community‐based teaching hospital, United States | |
| Participants | 35 adult and paediatric patients (minimum age of 2 years) with facial and scalp lacerations, ≤ 6 cm in length | |
| Interventions | 1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 10.4%), applied for 20 minutes (n = 18) 2. Topical TLE solution (lidocaine 5% and epinephrine 1:2000), applied for 20 minutes (n = 17) | |
| Outcomes | 1. The participant reported discomfort using a facial effective pain scale (1‐9), which consisted of 9 faces with various emotional expressions. However, in a few cases, the participant was too young to use the pain scale, so the physician estimated the participant's pain using the same Faces scale. The study combined self‐reported and surrogate Faces pain scale scores in the final results.
2. Rescue lidocaine infiltration was required.
3. The study reported any acute adverse reactions directly related to the anaesthetic. Results included the following. 1. Faces pain scale (1‐9) scores (mean score ± SD: topical TLE = 3.29 ± 1.92 vs topical TAC = 2.66 ± 1.78; P = 0.33) 2. Requirement for supplemental lidocaine infiltration (topical TLE = 6% vs topical TAC = 6%; P = not reported) 3. No acute anaesthetic‐related adverse effects |
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| Intervention dates | May to August 1992 | |
| Declaration of interest | Not reported | |
| Notes | Funding not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "The TAC and TLE solutions were arbitrarily assigned to a single‐dose (10ml), sequentially numbered vials by the pharmacist. The vials, with the specific contents unknown to the emergency physician, were forwarded to the ED as requested". Comment: probably not done |
| Allocation concealment (selection bias) | Low risk | Quote: "The solutions were made visibly identical by adding methylene blue to the TLE solution so that it matched the intrinsic blue colour of TAC". "The vials, with the specific contents unknown to the emergency physician, were forwarded to the ED as requested". Comment: probably done |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "The solutions were made visibly identical by adding methylene blue to the TLE solution so that it matched the intrinsic blue colour of TAC". Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 35 participants in study but reporting of attrition or exclusions insufficient to permit judgement |
| selective reporting of outcomes All outcomes | Low risk | All outcomes described in Methods were fully reported in Results section. Adverse events noted |
| Other bias (sample size) | High risk | Total N = 35: 17 participants in the TLE group; 18 in the TAC group |