| Methods |
Design: five group parallel trial
Purpose: examine the analgesic effect of EMLA cream (lidocaine and prilocaine) on pain associated with extracorporeal lithotripsy, and if effective, to examine which component (the cutaneous anaesthesia, the cream or the occlusive dressing) contributes to the analgesia |
| Participants |
Patients: out‐patients undergoing pain inducing extracorporeal lithotripsy because of renal stones
Baseline comparability: yes |
| Interventions |
Placebo: no occlusive dressing
‐occlusive dressing without cream
Untreated: no dressing or cream
Experimental: 3 groups received occlusive dressing with and without cream
(Co‐intervention: no) |
| Outcomes |
Pain (numerical verbal pain scale, 0 to 100) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Blinding?
Treatment provider |
Low risk |
' A randomized, double‐blind, crossover study...' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
|
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 82 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
|
