Vinci 1996.
| Methods | Single‐centre RCT, urban paediatric emergency department, Boston, Massachusetts, United States | |
| Participants | 156 patients, 3 to 18 years old, with lacerations on the face/scalp (n = 102), extremity (n = 47) or trunk (n = 7) | |
| Interventions | 1. TAC 1 solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for 15 to 30 minutes (n = 49) 2. TAC 2 solution (tetracaine 1.0%, epinephrine 1:2000, cocaine 4.0%), applied for 15 to 30 minutes (n = 49) 3. TAC 3 solution (tetracaine 1.0%, cocaine 4.0%), applied for 15 to 30 minutes (n = 58) | |
| Outcomes | 1. Physician rating of anaesthetic effectiveness (complete, partial or no anaesthesia). Anaesthesia was 'complete' if the participant did not move, flinch or grimace during repair. Anaesthesia was 'partial' if the participant complained of pain, moved or grimaced. If supplemental lidocaine infiltration was required, then 'no anaesthesia' was given.
2. Requirement for a second application of topical anaesthetic
3. Requirement for supplemental lidocaine infiltration
4. The study reported acute adverse effects directly due to the anaesthetic. Results for TAC 1 (standard formulation) vs TAC 3 (tetracaine‐cocaine) include the following. 1. Incidence of complete anaesthesia (topical TAC 1 = 73% vs topical TAC 3 = 28%; P < 0.001) 2. Requirement for a second dose of topical anaesthetic (topical TAC 1 = 30% vs topical TAC 3 = 66%; P < 0.003) 3. Requirement for supplemental lidocaine infiltration (topical TAC 1 = 6% vs topical TAC 3 = 9%; P = not reported) Results for TAC 2 (higher concentration tetracaine, lower concentration cocaine) vs TAC 3 (tetracaine‐cocaine) include the following. 1. Incidence of complete anaesthesia (topical TAC 2 = 63% vs topical TAC 3 = 28%; P < 0.001) 2. Requirement for a second dose of topical anaesthetic (topical TAC 2 = 46% vs topical TAC 3 = 66%; P < 0.003) 3. Requirement for supplemental lidocaine infiltration (topical TAC 2 = 2% vs topical TAC 3 = 9%; P = not reported) 4. A single paediatric participant developed an erythematous rash 1 day after application of standard topical TAC. |
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| Intervention dates | Not reported | |
| Declaration of interest | No explicit documentation regarding conflicts of interest | |
| Notes | Source of funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The solutions were batched in lots of 10 doses to limit expiration of the study drugs. The order of batching was generated using a standard table of random numbers". Comment: probably done |
| Allocation concealment (selection bias) | High risk | Quote: "The order of batching was generated using a standard table of random numbers". Comment: probably not done |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "...we conducted a randomized, prospective, double‐blind, clinical trial comparing three different formulations of cocaine‐containing topical anaesthetics". Unclear: In the Introduction section, reported to be a double‐blind study, but no details provided in Methods or any other sections |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | A total of 165 participants were randomized in the study, and no missing outcome data or exclusions |
| selective reporting of outcomes All outcomes | Low risk | The study protocol is available, and all of the study’s prespecified outcomes have been reported in the prespecified way. |
| Other bias (sample size) | High risk | 165 participants: 1. TAC 1 solution, n = 49 2. TAC 2 solution, n = 49 3. TAC 3 solution, n = 58 |