Table 3.
Summary of Findings for Comparison between Ketofol and Combined Agents
| Ketofol compared to a combined agent for procedural sedation and analgesia | |||||
|---|---|---|---|---|---|
| Patient or population: Procedural Sedation and Analgesia Intervention: Ketofol Comparison: Combined agent | |||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | |
| Risk with combined agent | Risk with ketofol | ||||
| Recovery time | The mean recovery time was 0 | MD 0.75 higher (6.24 lower to 7.74 higher) | – | 404 (6 RCTs) | ⊕ ⊕ ⊕⊝ MODERATE a |
| Recovery time - Dosage ratio 1:1 | The mean recovery time - Dosage ratio 1:1 was 0 | MD 7.95 lower (21.86 lower to 5.96 higher) | – | 166 (3 RCTs) | ⊕ ⊕ ⊝⊝ LOW b c |
| Recovery time - Dosage ratio 1:2 | The mean recovery time - Dosage ratio 1:2 was 0 | MD 14.62 higher (11.09 lower to 40.33 higher) | – | 148 (2 RCTs) | ⊕ ⊕ ⊝⊝ LOW b c |
| Desaturation | Study population | RR 1.90 (0.15 to 23.60) | 150 (2 RCTs) | ⊕ ⊕ ⊝⊝ LOW a c | |
| 54 per 1000 | 103 per 1000 (8 to 1000) | ||||
| Respiratory depression | Study population | RR 1.98 (0.18 to 21.94) | 116 (2 RCTs) | ⊕ ⊕ ⊝⊝ LOW a c | |
| 68 per 1000 | 134 per 1000 (12 to 1000) | ||||
| Hypotension | Study population | RR 0.42 (0.20 to 0.85) | 208 (3 RCTs) | ⊕ ⊕ ⊕⊝ MODERATE c | |
| 194 per 1000 | 82 per 1000 (39 to 165) | ||||
| Bradycardia | Study population | RR 0.70 (0.14 to 3.63) | 298 (4 RCTs) | ⊕ ⊕ ⊝⊝ LOW a c | |
| 109 per 1000 | 76 per 1000 (15 to 395) | ||||
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*The risk in the intervention group (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). CI: Confidence interval; MD: Mean difference; RR: Risk ratio. | |||||
|
GRADE (Working Group grades of evidence) High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | |||||
Footnote:
a Results show large heterogeneity that can be due to the following: 1) different populations: some procedures required a longer duration of treatment, thus, larger doses are required. 2) different ratios of the mixture and dosages of the combination
b Results show large heterogeneity that can be due to different populations and durations of procedures that determine the required dose of intervention
c Small sample size