Smith 1996.
| Methods | Single‐centre RCT, emergency department, Children’s Hospital, Columbus, Ohio, United States | |
| Participants | 240 patients, 2 to 17 years old, with lacerations ≤ 5 cm located on the face (n = 134), scalp (n = 57) or extremity (n = 49) | |
| Interventions | 1. Bupivanor (BN) solution (0.48% bupivacaine with 1:26,000 norepinephrine), applied for 20 minutes (n = 30) 2. Etidonor (EN) solution (0.95% etidocaine with 1:26,000 norepinephrine), applied for 20 minutes (n = 30) 3. Mepivanor (MN) solution (1.90% mepivacaine with 1:26,000 norepinephrine), applied for 20 minutes (n = 30) 4. Prilonor (PN) solution (3.81% prilocaine with 1:26,000 norepinephrine), applied for 20 minutes (n = 30) 5. TAC solution (tetracaine 1.00%, epinephrine 1:4000, cocaine 4.0%), applied for 20 minutes (n = 60) 6. Infiltrated lidocaine 1% (n = 60) | |
| Outcomes | 1. Participants 5 years of age or older, with reported discomfort on the VAS (100 mm) pain scale
2. Observer‐reported VAS (100 mm) pain scale scores (suture technicians and research assistants)
3. Observer‐reported Likert (1‐7) pain scale scores (parents and suture technicians).
4. Observer‐rated (RICDRS) Restrained Infants and Children Disress Rating Scale (0‐8) (research assistant and suture technician)
5. Suture technician‐rated anaesthetic effectiveness scale Results (topical BN vs topical EN vs topical MN vs topical PN vs topical TAC vs infiltrated local anaesthetic) include the following. (standard deviations not reported for any outcomes) 1. Participant‐reported VAS (100 mm) pain scores (mean scores: topical BN = 18.3 vs topical EN = 46.5 vs topical MN = 27.0 vs topical PN = 36.0 vs topical TAC = 12.0 vs infiltrated local anaesthetic = 26.3) (TAC significantly outperformed EN; P < 0.05; no significant differences between any other groups) 2a. Suture technician‐reported VAS (100 mm) pain scores (mean scores: topical BN = 2.0 vs topical EN =6.3 vs topical MN = 4.8 vs topical PN = 6.2 vs topical TAC = 2.8 vs infiltrated local anaesthetic = 2.0 (EN significantly outperformed by BN, TAC and infiltrated anaesthetic; P < 0.05; no significant differences between any other groups) 2b. Research assistant‐reported VAS (100 mm) pain scores (mean scores: topical BN =3.3 vs topical EN =7.7 vs topical MN = 4.9 vs topical PN = 8.9 vs topical TAC = 2.9 vs infiltrated local anaesthetic = 1.9) (TAC outperformed both EN and PN; P < 0.05; infiltrated anaesthetic outperformed both EN and PN; P < 0.05; no significant differences between any other groups) 3a. Suture technician‐reported Likert (1‐7) pain scores (mean scores: topical BN = 2.05 vs topical EN = 2.6 vs topical MN = 2.4 vs topical PN = 2.1 vs topical TAC = 1.55 vs infiltrated local anaesthetic = 1.6 (TAC outperformed both EN and MN; P < 0.05; infiltrated anaesthetic outperformed both EN and MN; P < 0.05; no significant differences between any other groups) 3b. Parent‐reported Likert (1‐7) pain scores (mean scores: topical BN = 2.8 vs topical EN = 3.5 vs topical MN = 3.3 vs topical PN = 3.6 vs topical TAC = 2.11 vs infiltrated local anaesthetic = 2.33 (TAC outperformed EN, MN and PN; P < 0.05; infiltrated anaesthetic outperformed EN and PN; P < 0.05; no significant differences between any other groups) 4a. Suture technician‐reported RICDRS (0‐8) (mean scores: topical BN = 2.5 vs topical EN = 3.6 vs topical MN = 2.3 vs topical PN = 2.5 vs topical TAC = 1.4 vs infiltrated local anaesthetic = 1.63 (TAC outperformed EN; P < 0.05; infiltrated anaesthetic outperformed EN; P < 0.05; no significant differences between any other groups) 4b. Research assistant‐reported RICDRS (0‐8) (mean scores: topical BN = 2.4 vs topical EN = 3.1 vs topical MN = 2.7 vs topical PN = 2.9 vs topical TAC = 1.6 vs infiltrated local anaesthetic = 1.8 (TAC outperformed both EN and PN; P < 0.05; infiltrated anaesthetic outperformed EN; P < 0.05; no significant differences between any other groups) 5. Anaesthetic effectiveness scale (scores not reported) (TAC outperformed EN and MN; P < 0.05; infiltrated anaesthetic outperformed BN, EN, MN, PN; P < 0.05; no significant differences between any other groups) |
|
| Intervention dates | July to December 1992 | |
| Declaration of interest | No explicit documentation regarding conflicts of interest | |
| Notes | Source of funding: Ohio State University Seed Grant Program, Bremer Research Foundation, Ohio State University and Samuel J. Roessler Memorial Scholarship Fund Study author contacted to request additional study data; study author replied but unable to provide the missing information. High risk of bias for local anaesthetic vs topical anaesthetic, as this comparison was not blinded. However,unclear risk of bias in 3 domains for comparisons of different topical anaesthetics because of appropriate blinding |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Study patients were assigned to one of six anaesthetic treatment groups using block randomization". Comment: unclear, as exact method of selecting the blocks was not reported |
| Allocation concealment (selection bias) | Unclear risk | Comment: unclear |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Comparisons among the five topical preparations were double blinded. Because lidocaine was given as an injection, its identity was not blinded"; "Anesthetics were prepared in advance by Children's Hospital pharmacy, sealed in envelopes labelled with a study identification number, and stored in a locked cabinet in the emergency department". Comment: probably blinded between comparisons of different topical agents, but probably not blinded between comparisons of infiltrated lidocaine and topical anaesthetic |
| 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 participants enrolled: 1. Bupivanor (BN) solution, n = 30 2. Etidonor (EN) solution, n = 30 3. Mepivanor (MN), n = 30 4. Prilonor (PN) solution, n = 30 5. TAC solution, n = 60 6. Infiltrated lidocaine, n = 60 |