Primary and secondary outcomes
| Variable | Midazolam+placebo (n=29) | Midazolam+ketamine (n=31) | Mean difference (95% CI) | p Value |
|---|---|---|---|---|
| Procedure duration (min)±SD | 10.9±5.32 | 15.75±6.53 | 4.85 (1.28 to 8.42) | 0.009 |
| Time to achieving a sedation scale ≤4 (min)±SD | 17.93±6.9 | 14.59±6.3 | 3.35 (−0.83 to 7.53) | 0.11 |
| Time from drug administration to procedure (min)±SD | 28.43±10.82 | 24.76±7.17 | 3.67 (−1.85 to 9.19) | 0.15 |
| Failure of oral sedation | 8 (27%) | 2 (6%) | 0.039 | |
| VAS by investigator (CM)±SD | 4.49±3.16 | 4.05±2.87 | 0.44 (−1.29 to 2.16) | 0.61 |
| VAS by parent (CM)±SD | 4.40±2.78 | 4.50±3.33 | 0.1 (−1.9 to 1.71) | 0.91 |
| Sedation scale during procedure±SD | 3.50±0.67 | 2.36±0.89 | 1.14 (0.67 to 1.6) | 0.001 |
| Time from drug administration to discharge (min)±SD | 121.76±31.20 | 186.79±93.10 | 65 (22 to 107) | 0.003 |
| Adverse events (%) | 2 (6.9) | 6 (19) | 0.26 |
VAS, visual analogue scale.