Anderson 1990.
Methods | Single‐centre RCT, paediatric emergency department, United States | |
Participants | 151 patients younger than 18 years old with lacerations on the scalp (n = 31), face (n = 79) or extremity (n = 41) | |
Interventions | 1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for 5 to 10 minutes (n = 56) 2. Intradermal infiltration with lidocaine 1% (n = 53) 3. Topical placebo solution, applied for 5 to 10 minutes (n = 42) | |
Outcomes | 1. Before laceration repair, the physician probed the wound with a 25‐gauge needle to determine adequacy of initial anaesthesia.
2. The physician graded participant compliance during the suturing process on a 4‐point scale (1 ‐ complete compliance, 2 ‐ occasional resistance, 3 ‐ frequent resistance, 4 ‐ continuous resistance).
3. Supplemental lidocaine infiltration was required. Results of topical TAC versus topical placebo include the following. 1. Adequate initial anaesthesia (topical TAC = 89% vs topical placebo = 17%; P < 0.0001) 2. Physician compliance scale (1‐4) ratings (complete compliance to continuous resistance) (mean score ± SD: topical TAC = 1.25 ± 0.57 vs topical placebo = 1.93 ± 0.96; P < 0.002) 3. Requirement of supplemental lidocaine infiltration (topical TAC = 18% vs topical placebo = 83%; P < 0.0001) Results of topical TAC versus infiltrated local anaesthetic include the following. 1. Adequate initial anaesthesia (topical TAC = 89% vs infiltrated local anaesthetic = 79%; P = non‐significant) 2. Physician compliance scale (1‐4) ratings (complete compliance to continuous resistance) (mean score ± SD: topical TAC = 1.25 ± 0.57 vs infiltrated local anaesthetic = 1.94 ± 1.12; P < 0.002) 3. Requirement of supplemental lidocaine infiltration (topical TAC = 18% vs infiltrated local anaesthetic = 23%; P = non‐significant) |
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Intervention dates | August 1986 to May 1987 | |
Declaration of interest | Not reported | |
Notes | Funding not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "The last digit of the patient's medical record number was used to enter patients into either the intradermal or topical group". Comment: probably not done |
Allocation concealment (selection bias) | High risk | Quote: "The last digit of the patient's medical record number was used to enter patients into either the intradermal or topical group". Comment: probably not done |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "Individual study vials containing 5ml of TAC or placebo were prepared in the pharmacy of University of Massachusetts Medical Center following a standard protocol and assigned numbers"; "The ED staff member evaluating and suturing the patient were blind to the solution contained in the vials". Comment: Comparisons of topical TAC and topical placebo were probably blinded. However, comparisons between lidocaine infiltration and topical TAC were probably unblinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 153 eligible patients, 2 refused to participate. 151 randomized, no missing outcome data |
selective reporting of outcomes All outcomes | Unclear risk | All outcomes discussed in Methods section reported in Results. Subgroup analysis based on location of laceration was not prespecified. |
Other bias (sample size) | High risk | 56 TAC: 53 lidocaine 42 placebo |