Resch 1998.
Methods | Single‐centre RCT, emergency department, University of Minnesota‐affiliated Children’s Hospital, Minneapolis, Minnesota, United States | |
Participants | 194 paediatric patients with lacerations of the face and scalp | |
Interventions | 1. Topical LAT solution (lidocaine 4%, epinephrine 1:2000, tetracaine 0.5%), applied for 20 minutes (n = 103) 2. Topical LAT gel (lidocaine 4%, epinephrine 1:2000, tetracaine 0.5%), applied for 20 minutes (n = 91) | |
Outcomes | 1. The physician assessed the adequacy of initial anaesthesia by probing the wound with a 27‐gauge needle. If any pain was elicited with probing, the anaesthetic was considered 'inadequate' and infiltrated lidocaine was given.
2. At the conclusion of laceration repair, the physician rated anaesthetic effectiveness (complete, partial or incomplete) based on painful responses during suturing.
3. The study reported acute adverse reactions directly related to the anaesthetic. Results include the following. 1. Adequacy of initial anaesthesia (adequate anaesthesia: LET solution = 84% vs LET gel = 82%; P > 0.05) 2. Effectiveness of anaesthesia (complete anaesthesia: LET solution = 76% vs LET gel = 85%; P = 0.007) 3. No acute anaesthetic‐related adverse effects |
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Intervention dates | March 1995 to March 1996 | |
Declaration of interest | Not reported | |
Notes | Funding not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A computer‐generated random number table was used by a hospital pharmacy personnel to label standard amber vials from 1 to 200". Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote: :hospital pharmacy personnel to label standard amber vials from 1 to 200" "it was required that the study medication be applied by a nurse not involved in the suturing" Comment: probably done |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "To ensure blinding of suture personnel, in the trial, it was required that the study medication be applied by a nurse not involved in the suturing" Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 200 participants enrolled and 3 withdrawn before test of initial anaesthesia because participants were unco‐operative or complicated laceration did not meet inclusion criteria. Of the 197 available for analysis, 3 data sheets were inadvertently lost. We concluded low risk of bias because plausible effect size among missing outcomes was not enough to have a clinically relevant impact on observed effect size. |
selective reporting of outcomes All outcomes | Unclear risk | All prespecified primary and secondary outcomes were reported: physician determination of adequacy of anaesthetic before repair and anaesthetic effectiveness during repair. Adverse effects also reported Quote: “Pain assessment was a 2‐stage process that evaluated adequacy of anaesthesia before suturing and effectiveness of anaesthesia during suturing”. “Effectiveness of anaesthesia during suturing was divided into 3 categories: complete, partial, and incomplete”. “Complications assessed were redness, drainage, fever, tenderness, swelling, or contact with medical personnel for wound‐related issues other than suture removal”. Quote: “Of the 194 patients, 162 (83.5%) obtained adequate anaesthesia as determined by the 27‐gague needle test”. Table 3. Efficacy of LET solution versus LET gel for topical anaesthesia of face and scalp (includes information on complete, partial and Incomplete effectiveness) Complications: “No adverse effects were noted in the 194 patients during the procedure. 13 patients who were not able to be contacted… one patient in each study arm sought medical care for a wound infection". |
Other bias (sample size) | Unclear risk | Quote: “LET solution = 103 subjects, LET gel = 91 subjects” |