Smith 1998a.

Methods	Single‐centre RCT, emergency department or a large children’s hospital, United States
Participants	180 patients, 1 to 18 years old, with lacerations ≤ 5 cm, located on the face (n = 76), scalp (n = 59), extremity (n = 43) or other (n = 2)
Interventions	1. Prilophen (PP) solution (3.56% prilocaine, 0.10% phenylephrine), applied for 20 minutes (n = 60) 2. Bupivaphen (BP) solution (0.67% bupivacaine, 0.10% phenylephrine), applied for 20 minutes (n = 60) 3. TAC solution (tetracaine 1.0%, epinephrine 1:4000, cocaine 4.0%), applied for 20 minutes (n = 60)
Outcomes	1. Participants 5 years of age and older self‐reported pain using a VAS (100 mm) scale. 2. Observer‐reported VAS (100 mm) pain scale scores (suture technicians, research assistants and parents) Results (topical PP vs topical BP vs topical TAC) included the following. 1. Participant self‐reported VAS (100 mm) pain scores (mean score ± SD: topical PP = 21.0 ± 28.0 vs topical BP = 41.0 ± 35.0 vs topical TAC = 18.0 ± 24.0) (no differences reported between groups; P = 0.07) 2a. Suture technician‐rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 3.8 ± 8.5 vs topical BP = 5.0 ± 9.0 vs topical TAC = 1.5 ± 3.0) (Topical TAC outperformed topical BP; P = 0.006; no differences between TAC and PP; no differences between BP and PP) 2b. Research assistant‐rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 3.0 ± 6.0 vs topical BP = 3.8 ± 4.9 vs topical TAC = 1.4 ± 2.1) (Topical TAC outperformed topical BP; P = 0.002; no differences between TAC and PP; no differences between BP and PP) 2c. Parent‐rated VAS (100 mm) pain scores (mean score ± SD: topical PP = 24.0 ± 24.5 vs topical BP = 29.0 ± 28.0 vs topical TAC = 17.0 ± 20.5) (TAC outperformed BP; P = 0.03; no differences between TAC and PP; no differences between BP and PP)
Intervention dates	Not reported
Declaration of interest	Not reported
Notes	Funding source: supported by Grant 020‐898 from the Children’s Hospital Research Foundation, Columbus, Ohio. Stipend support for medical students was provided by the Samuel L. Roessler Memorial Medical 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: "68 patients were assigned to each of the three anaesthetic treatment groups using block randomization". Comment: unclear, as exact method of selecting the blocks not reported
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..." "Anesthetics were sealed in envelopes labelled with a study identification number and stored in a locked cabinet in the ED". Comment: probably done, assuming solutions visually identical
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	180 participants included in the study but reporting of attrition or exclusions insufficient to permit judgement
selective reporting of outcomes All outcomes	Low risk	All prespecified primary and secondary outcomes were reported: VAS pain scores during suturing by participants and observers (suture technicians, research assistants, parents) Quote: “Pain perceptions of suture technicians, research assistants, parents and patients 5 years of age and older were ascertained using a visual analogue scale (VAS)… Observers based pain scores on the pain experienced as the needle pierced the skin in order to measure actual anaesthetic performance”. Figure 1. Mean VAS pain score by anaesthetic treatment group for suture technicians compared with research assistants for all types of laceration of repair. Figure 2. Mean VAS pain score by anaesthetic treatment group for participants compared with parents for all types of laceration repair. Figure 3. Mean VAS pain score by anaesthetic treatment group for suture technicians compared with research assistants for only face and scalp laceration repairs. Figure 4. Mean VAS pain score by anaesthetic treatment group for participants compared with parents for face and scalp lacerations only. Additional reporting: 1. Complications at follow‐up were listed as “2 wound infections, 1 case of wound drainage that resolved without antibiotics, 3 cases of lost stitches, and 3 cases of wound dehiscence”.
Other bias (sample size)	Unclear risk	Quote: “Participants were 180 children. Three groups each of 60 subjects each: TAC vs Prilophen vs Bupivaphen".