Kendall 1996.
Methods | Single‐centre RCT, Accident and Emergency Department of Gloucestershire Royal Hospital, United Kingdom | |
Participants | 107 paediatric patients, 3‐16 years old, with lacerations < 4 cm in length, located anywhere on the body except mucous membranes or digits | |
Interventions | 1. Topical AC solution (epinephrine 1:2000, cocaine 4.7%), applied for 10‐15 minutes (n = 51) 2. Intradermal infiltration with lidocaine 1% (n = 51) | |
Outcomes | 1. Children younger than 10 years of age rated pain during both laceration repair and anaesthetic application using the Wong‐Baker Faces Scale. Patients 10 years of age or older used a VAS (10 cm) score to rate pain during suturing and anaesthetic administration.
2. Physician‐rated VAS (10 cm) pain scale scores
3. Parent‐rated VAS (10 cm) pain scale scores
4. Parent rated overall acceptability of the procedure.
5. Study reported any acute adverse effects to the anaesthetic. Results include the following. (standard deviations not reported) 1. Participant‐rated pain scores (pooled VAS and Wong‐Baker Faces scores) (mean score: topical AC = 4.50 vs infiltrated local anaesthetic = 4.40; P = NS) 2. Physician‐rated VAS (10 cm) pain scale scores (mean score: topical AC = 2.60 vs infiltrated local anaesthetic = 3.60; P = NS) 3. Parent‐rated VAS (10 cm) pain scale scores (mean score: topical AC = 3.10 vs infiltrated local anaesthetic = 3.80; P = NS) 4. Parent rating of overall acceptability of the procedure (topical AC = 14.5% unacceptable vs infiltrated local anaesthetic = 39% unacceptable; P < 0.01) 5. No acute anaesthetic‐related adverse effects |
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Intervention dates | January to November 1994 | |
Declaration of interest | No explicit documentation regarding conflicts of interest | |
Notes | No sources of funding mentioned | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Children presenting with an appropriate laceration were consecutively assigned to receive either conventional intradermal lignocaine or topical AC preparation". Comment: probably not done |
Allocation concealment (selection bias) | High risk | Quote: "consecutively assigned to receive either conventional intradermal lignocaine or topical AC preparation" "Groups could not be blinded". Comment: probably not done |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "The nature of the trial meant that the two groups could not be blinded". Comment: probably not done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 120 participants were enrolled but 13 were excluded before data analysis (incomplete data collection for 8, 2 received Steristrips and not sutures, 3 did not attend follow‐up). We concluded low risk of bias because reasons for exclusion were unlikely to be related to pain scores during laceration repair. |
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 | 1. Topical AC solution, n = 56 2. Intradermal infiltration with lidocaine, n = 51 |