Pryor 1980.
Methods | Single‐centre RCT, Army Medical Center emergency department, United States | |
Participants | 158 adult and paediatric patients, range 10 months to 53 years old (mean = 9 years old) | |
Interventions | 1. Topical TAC solution (tetracaine 0.5%, epinephrine 1:2000, cocaine 11.8%), applied for minimum of 10 minutes (n = 82) 2. Intradermal infiltration with lidocaine (n = 76) | |
Outcomes | 1. Participants 10 years of age or older rated anaesthetic efficacy (complete, partial or none) depending on whether they experienced pain during laceration repair.
2. Also, after completion of wound repair, participant or parent rated anaesthetic acceptability (excellent, good or poor). Results include the following. 1. Verbal rating (complete, partial or none) of anaesthetic efficacy (complete: topical TAC = 84% vs infiltrated local anaesthetic = 88%; P = not reported) 2. Anaesthetic acceptability: Participants 17 years of age and younger preferred topical TAC (P < 0.005); no difference between the 2 anaesthetic groups among participants older than 17 years of age. |
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Intervention dates | October to December 1979 | |
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: "A prospective study of topical TAC and lidocaine infiltration was taken with the last digit of the patients military sponsor's social security number used as the selection variable, odd numbered patients were anaesthetised with topical TAC; even numbered patients were anaesthetised with lidocaine". Comment: probably not done |
Allocation concealment (selection bias) | High risk | Quote: "the last digit of the patient's military sponsor's social security number used as the selection variable" Comment: probably not done. Anaesthetic agents visually different, and no mention of safeguards to prevent concealment of identity |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: none Comment: probably not blinded, as the paper did not state whether participants or clinicians were blinded between topical and infiltrated anaesthetics |
Incomplete outcome data (attrition bias) All outcomes | Low risk | A total of 158 participants enrolled with no drop‐outs or exclusions. |
selective reporting of outcomes All outcomes | High risk | All outcomes described in Methods section were reported in Results, but method of assessing anaesthetic adequacy appears inconsistent between Methods and Results sections. Subgroup analysis by age was described in Methods, but results were not presented for all subgroups for each outcome. Wound complications were measured at 3 time points, but results were presented only for overall rate. No adverse events due to anaesthetic administration were reported. Some results are presented only graphically. |
Other bias (sample size) | Unclear risk | 82 received topical TAC and 76 received lidocaine infiltration for anaesthesia. |