| Methods |
Design: five group parallel trial
Purpose: examine the effect of topical anaesthesia methods for venous cannulation in adults |
| Participants |
Patients: patients in need of cannulation
Baseline comparability: yes ('demographic data') |
| Interventions |
Placebo: cream without EMLA
Untreated: no cream
Experimental:
‐cream with EMLA
‐ethylchloride spray
‐lidocaine infiltration
(Co‐intervention: yes, midazolam) |
| Outcomes |
Pain ratings (VAS)
Number of patients with difficult punctures |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Unclear information |
| Allocation concealment? |
Unclear risk |
Unclear information |
| Blinding?
Treatment provider |
Low risk |
'The study was double‐blinded to the degree that the methodologies allowed' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcomes |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
Low risk |
N = 58 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Unclear allocation concealment |
