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Table 2 Intravenous midazolam compared to intravenous placebo for sedation before procedures

From: Midazolam for sedation before procedures in adults and children: a systematic review update

Patient or population: Adults requiring sedation before gastrointestinal endoscopy and bronchoscopy, adults requiring nasogastric tube insertion in an emergency department and children
Settings: Hospitals in India, Iran, UK, Portugal, USA and Japan
Intervention: Intravenous midazolam
Comparison: Placebo
Outcomes Illustrative comparative risksa (95% CI) Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed risk Corresponding risk
Placebo Intravenous midazolam
Level of sedation on a sedation assessment scale
The Ramsay scale was used (numerical scale that ranged from 1 to 6 with higher scores indicating the participant was more sedated)
1.19 1 Higher
(from 0.6 higher to 1.4 higher
  100
(1 study)
Low1
 
Numeric rating of anxiety or number of participants rated as anxious
Number of participants rated as anxious
333 per 1000 143 per 1000
(30 to 663)
RR 0.43
(0.09 to 1.99)
123
(2 studies)
low2
 
Proportion of incomplete procedures or where there was difficulty performing the procedures 216 per 1000 108 per 1000
(63 to 186)
RR 0.50
(0.29 to 0.86)
223
(3 studies)
Low3
 
Discomfort/pain 168 per 1000 86 per 1000
(42 to 175)
RR 0.51
(0.25 to 1.04)
190
(2 studies)
Low4
 
  1. aThe basis for the assumed risk is the control group risk across studies or the average risk for pooled data and the control group risk for single studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
  2. CI Confidence interval; RR Risk ratio
  3. GRADE Working Group grades of evidence
  4. High quality: Further research is very unlikely to change our confidence in the estimate of effect.
  5. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
  6. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
  7. Very low quality: We are very uncertain about the estimate.
  8. Footnotes
  9. 1Downgraded two levels due to concerns about the risk of bias (it was unclear how the allocation sequence was generated and concealed and how participants were blinded to the allocation) and imprecision (optimal information size was not met—single study with a small number of participants, no confidence intervals were reported)
  10. 2Downgraded two levels due to concerns about risk of bias (it was unclear in one study how the allocation sequence was generated and concealed and how participants were blinded to the allocation) and imprecision (optimal information size was not met—single study with a small number of participants, wide confidence intervals crossing the line of no effect, and including the potential for both benefit and harm)
  11. 3Downgraded two levels due to concerns about the risk of bias (it was unclear in one study how the allocation sequence was concealed) and imprecision (optimal information size was not met—wide confidence intervals including the potential for a very large benefit or very small degree of harm)
  12. 4Downgraded two levels due to concerns about the risk of bias (it was unclear in one study how the allocation sequence was concealed) and imprecision (optimal information size was not met—wide confidence intervals including the potential for a very large benefit or very small degree of harm)
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