| Methods |
Design: three group parallel trial
Purpose: study the effect of ethyl vinyl chloride spray on the pain associated with cannulation in children |
| Participants |
Patients: children (9 to18 years) undergoing cannulation
Baseline comparability: yes (age, gender ratio) |
| Interventions |
Placebo: isopropyl alcohol spray
Untreated: no spray
Experimental: ethyl vinyl chloride spray
(Co‐intervention: no) |
| Outcomes |
Pain intensity VAS |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'random number allocation' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'The investigators and nursing staff performin IV cannulation were blinded to the cannister's contents...' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| 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 = 90 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Not clearly concealed allocation |
