Bonadio 1990.
| Methods | Single‐centre RCT, Department of Emergency Medicine, Children’s Hospital Wisconsin, Milwaukee, Wisconsin, United States | |
| Participants | 55 paediatric patients with facial lacerations | |
| Interventions | 1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for 10 to 15 minutes (n = 24) 2. Topical AC solution (epinephrine 1:2000, cocaine 11.8%), applied for 10 to 15 minutes (n = 31) | |
| Outcomes | 1. The physician calculated the total number of 'sutures eliciting pain' using the following system. Each suture placed involved 2 points; an entrance and an exit piercing of the wound tissue with the needle. A painful response consisted of a verbal participant experiencing a painful sensation or a non‐verbal participant beginning to cry, or crying with greater intensity. The total number of 'sutures placed eliciting pain' was calculated by dividing the total number of painful responses by 2.
2. The study reported any acute adverse effects due to the anaesthetic. Results included the following. 1. The physician calculated the total number of 'sutures eliciting pain' (topical AC = 7/103 (4%) vs topical TAC = 7/151 (7%); P = not‐reported). 2. No acute anaesthetic‐related adverse effects were noted. |
|
| Intervention dates | Not reported | |
| Declaration of interest | No explicit documentation regarding conflicts of interest. | |
| Notes | Source of funding: general academic paediatric development fellowship from The Robert Wood Johnson Foundation; and Grant 10066 from The Robert Wood Foundation | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "...as in each case an assistant randomly selected one of the two solutions for physician application..." Comment: probably not done |
| Allocation concealment (selection bias) | High risk | Quote: "an assistant randomly selected one of the two solutions for physician application..." Comment: probably not done |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "The managing physician was 'blind' to which preparation was being administered...the physician was informed of the solution composition only after the suturing procedure and pain scoring were completed". Comment: probably done, assuming the 2 solutions were visually identical |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 55 participants in study but reporting of attrition or exclusions insufficient to permit judgement |
| 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 | 55 paediatric participants: 1. Topical TAC solution, n = 24 2. Topical AC solution, n = 31 |