| Methods |
Design: three group parallel trial
Purpose: examine the effect of fentanyl as premedication |
| Participants |
Patients: in‐patients undergoing same day surgery
Baseline comparability: yes |
| Interventions |
Placebo: oralet without fentanyl
Untreated: no oralet
Experimental: oralet with fentanyl
(Co‐intervention: NS) |
| Outcomes |
Anxiety (Spielberger state trait anxiety inventory)
Heart rate
Volume and pH of gastric contents
Arterial pressure
Respiratory frequency
Oxygen saturation |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
'by computer program' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'All investigators were blinded to the type of oralet patients in Groups I and II consumed...' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
Low risk |
N = 60 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
