White 1986.
| Methods | Single‐centre RCT, emergency department at Arizona Health Sciences Center, Arizona, United States | |
| Participants | 68 adult patients, older than 18 years of age, with lacerations < 5 cm in length, located on the face (n = 22) or non‐facial (n = 46) | |
| Interventions | 1. TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 10.0%), applied for 5 to 10 minutes (n = 36) 2. Tetracaine solution (tetracaine 0.5%), applied for 5 to 10 minutes (n = 32) | |
| Outcomes | 1. Participant‐rated numerical pain scale score (0‐10)
2. Requirement of supplemental lidocaine infiltration Results include the following. 1. Participant‐rated numerical pain scale (0‐10) score (mean pain scores: topical tetracaine = 5.6 vs topical TAC = 3.53; P < 0.05; standard deviations not reported) 2. Requirement for rescue lidocaine infiltration (topical tetracaine = 59% vs topical TAC = 36%; P = not reported) |
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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) | High risk | Quote: "Prior to delivery to the emergency department, the TAC and tetracaine solutions were assigned odd or even numbers"; "Randomization was achieved by matching the vials to the odd or even numbers at the end of the hospital number". Comment: probably not done |
| Allocation concealment (selection bias) | High risk | Quote: "Randomization was achieved by matching the vials to the odd or even numbers at the end of the hospital number". Comment: probably not done |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Only the pharmacist preparing the solutions knew which vials contained tetracaine and which contained TAC". Comment: probably done, assuming visually identical solutions |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 68 patients participated in the study. It is not clear whether the same number were randomized, or whether any were withdrawn. |
| 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 | Total N = 68: 1. TAC solution, n = 36 2. Tetracaine solution, n = 32 |