Lee 2013.
Methods | Single‐centre RCT, Department of Emergency Medicine, Singapore General Hospital | |
Participants | n = 40, > 1 year to 70 years (only 1 patient > 10 years old was included in the study), 29 males (72.5%), 11 females (27.5%). Length of the wounds was 3.1 cm for the LG group and 3.5 cm for the LI group. Depth of the wounds was 0.5 cm and 0.57 cm, respectively. | |
Interventions | 1. LAT gel (n = 23): mean length of wound/cm (SE) 3.1 cm (SE 0.31). Mean depth of wound/cm (SE) 0.5 (0.07). Location of wound: head 17/23 (74.0%), trunk 0/23 (0%) and limb 6/23 (26%) 2. Infiltrated lidocaine (n = 17): mean length of wound/cm (SE) 3.5 cm (SE 0.36). Mean depth of wound/cm (SE) 0.57(0.08). Location of wound: head 11/17 (64.7%), trunk 0/17 (0%) and limb 6/17 (35.3%) |
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Outcomes | 1. LAT gel: a. Efficacy: 10 cm VAS pain score by participant (mean ± SE) = 2.5 (0.52) b. Pain during application (mean ± SE): 1.5 (0.40) Pain score by parents, clinician or participants younger than 10 years old; results not provided 2. Lignocaine infiltration: a. Efficacy: 10 cm VAS pain score by participant (mean ± SE) = 2.6 (0.58) b. Pain during application (mean ± SE): 3.5 (0.46) Pain score by parents, clinician or participants younger than 10 years old; results not provided Complications: 1. No acute anaesthetic complications in either group 2. One week later, assessed for wound complications 1. LAT gel (study lists 25 but probably typographical error because only 23 participants in this treatment arm) a. Wound Infection, 5/25 (5/23?) b. Wound dehiscence = 1/25 (1/23?) c. Stitches lost = 1/25 (1/23?) 2. Lignocaine infiltration a. Wound Infection, 2/14 b. Wound dehiscence, 0/14 c. Stitches lost, 0/14 |
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Intervention dates | Janurary to April 2003 | |
Declaration of interest | None. | |
Notes | Souce of funding: none | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Suitable participants were assigned to 2 arms of treatment via sealed envelopes. However, precise method of sequence generation was not described. |
Allocation concealment (selection bias) | Unclear risk | Use of assigned envelopes described but information proved insufficient to allow a decision between low risk and high risk |
Blinding (performance bias and detection bias) All outcomes | High risk | Not blinded and outcome could be affected by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 40 patients recruited and no drop‐outs mentioned |
selective reporting of outcomes All outcomes | Low risk | All prespecified primary outcomes were reported. |
Other bias (sample size) | High risk | LAT gel = 23 participants Infiltrated lidocaine = 17 participants |