Smith 1997b.

Methods	Single‐centre RCT, emergency department, Children’s Hospital, Columbus, Ohio, United States
Participants	240 patients, 1 to 18 years of age, with lacerations ≤ 5 cm in length, located on the face (51%), scalp (30%), extremity (18%) or other site (1%)
Interventions	1. Prilophen (PP) solution (prilocaine 3.56%, phenylephrine 0.99%), applied for 20 minutes (n = 60) 2. Tetraphen (TP) solution (tetracaine 1.0%, phenylephrine 5.0%), applied for 20 minutes (n = 60) 3. Tetralidophen (TLP) solution (tetracaine 1.0%, lidocaine 1.0%, phenylephrine 2.5%), applied for 20 minutes (n = 60) 4. TAC solution (tetracaine 1.0%, epinephrine 1:4000, cocaine 4.0%), applied for 20 minutes (n = 60)
Outcomes	1. Participants 5 years of age or older reported VAS (100 mm) pain scale scores. 2. Observer‐reported VAS (100 mm) pain scale scores (suture technicians, research assistants and parents) 3. Observer‐reported Likert (1‐7) pain scale scores (suture technicians, research assistants and parents) 4. Suture technicians rated anaesthetic effectiveness (complete, partial or no anaesthesia) Results (topical PP vs topical TP vs topical TLP vs topical TAC) include the following. 1. Participant self‐reported VAS (100 mm) pain scores (mean score ± SD: topical PP = 29.0 ± 43.4 vs topical TP = 24.2 ± 37.2 vs topical TLP = 30.6 ± 40.3 vs topical TAC = 17.6 ± 34.1) (no reported differences between groups; P = 0.5) 2a. Suture technician‐rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 7.4 ± 16.0 vs topical TP = 5.1 ± 12.6 vs topical TLP = 6.0 ± 13.5 vs topical TAC = 3.5 ± 11.8) (Topical TAC performed significantly better then topical PP; reported P = 0.04.) 2b. Research assistant‐rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 1.6 ± 2.6 vs topical TP = 1.9 ± 4.2 vs topical TLP = 1.3 ± 1.7 vs topical TAC = 0.9 ± 1.7) (no reported differences between groups; P = 0.09) 2c. Parent‐rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 20.0 ± 21.7 vs topical TP = 20.2 ± 21.7 vs topical TLP = 18.2 ± 18.6 vs topical TAC = 14.0 ± 18.6) (no reported differences between groups; P = 0.09) 3a. Suture technician‐reported Likert (1‐7) pain scores (median score: topical PP = 2.0 vs topical TP = 1.0 vs topical TLP = 2.0 vs topical TAC = 1.0) (Topical TAC performed significantly better than topical PP or topical TLP; P = 0.01.) 3b. Research assistant‐reported Likert (1‐7) pain scores (median score: topical PP = 2.0 vs topical TP = 1.0 vs topical TLP = 2.0 vs topical TAC = 1.0) (Topical TAC performed significantly better than topical PP or topical TLP; P = 0.03.) 3c. Parent‐reported Likert (1‐7) pain scores (median score: topical PP = 2.0 vs topical TP = 2.0 vs topical TLP = 2.0 vs topical TAC = 2.0) (mo reported differences between any of the groups; P = 0.06) 4. Anaesthetic effectiveness (complete anaesthesia: topical PP = 63% vs topical TP = 67% vs topical TLP = 65% vs topical TAC = 80%) (mo reported differences between any of the groups; P =.18)
Intervention dates	June to September 1994
Declaration of interest	No explicit documentation regarding conflicts of interest
Notes	Source of funding: Grant 020‐898 from Children’s Hospital Research Foundation and Samuel J. Roessler Memorial Scholarship Fund Study author contacted to request additional study data; study author replied but unable to provide missing information
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were randomly assigned to one of four anaesthetic treatment groups.." Comment: unclear, as study was reported to be randomized but method of sequence generation was not described
Allocation concealment (selection bias)	Unclear risk	Comment: unclear
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Quote: "using a prospective, randomized, double‐blind design..." "Anesthetic agents were sealed in envelopes labelled with a study identification number and stored in a locked cabinet in the emergency department". Comment: probably done, assuming topical solutions visually identical
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	240 participants included in the 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)	Unclear risk	240 children enrolled: 1. Prilophen (PP) solution, n = 60 2. Tetraphen (TP) solution, n = 60 3. Tetralidophen (TLP) solution, n = 60 4. TAC solution, n = 60