| Methods |
Design: three group parallel trial
Purpose: examine the tolerance and technical difficulty (and cardiorespiratory adverse effects) of sedative premedication during colonoscopy |
| Participants |
Patients: out‐patients undergoing colonoscopy
Baseline comparability: yes (age, gender) |
| Interventions |
Placebo: saline injections
Untreated: no injections
Experimental: midazolam injections
(Co‐intervention: NS) |
| Outcomes |
Overall difficulty of colonoscopy, patient's report post procedure and after 2 weeks (100 mm VAS)
Abdominal pain, patient's report (100 mm VAS)
Discomfort, patient's report (100 mm VAS)
Overall difficulty of colonoscopy, observer's report (100 mm VAS)
Abdominal pain, observer's report (100 mm VAS)
Discomfort, observer's report (100 mm VAS)
Oxygen saturation in %
Arterial blood pressure
R‐R intervals on continuous ECG readings |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'An injection was administered for 30 to 60 seconds in a double‐blind manner...' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| 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? |
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 = 122 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
