Summary of findings 1. Infraorbital nerve block compared with placebo for cleft lip repair in children.
Infraorbital nerve block compared with placebo for cleft lip repair in children | ||||||
Patient or population: children with cleft lip Settings: hospital Intervention: infraorbital nerve block Comparison: placebo | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Placebo | Infraorbital nerve block | |||||
Pain score control Different scales (0 to 4 hours) |
‐ | The mean pain in the intervention groups was ‐3.54 standard deviations lower (‐6.13 to ‐0.95 lower) | ‐ | 120 (3) | ⊕⊝⊝⊝ very low1,2,3 | A standard deviation of 3.54 represents a large difference between groups |
Duration of postoperative analgesia (in hours) |
‐ | The mean duration of postoperative analgesia in the intervention group was 8.26 higher (5.41 to 11.11 higher) |
‐ | 60 (1) |
⊕⊝⊝⊝ very low1,2,4 | ‐ |
Adverse events | 2 out of 3 studies reported this outcome. One study reported no differences between groups, and the other study reported more vomiting in the placebo group | |||||
Supplemental analgesic requirements (at 4 hours) |
Low‐risk population | RR 0.05 (0.01 to 0.18) |
120 (3) |
⊕⊕⊝⊝ low 1,2 | ‐ | |
600 per 1000 | 30 per 1000 (6 to132) | |||||
High‐risk population | ||||||
567 per 1000 | 28 per 1000 (6 to 125) | |||||
Time to feeding after surgery | This outcome was not reported | |||||
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. 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). CI: confidence interval; RR: risk ratio | ||||||
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. 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. Very low quality: We are very uncertain about the estimate. |
1Downgraded one level: few studies with small sample size.
2Downgraded one level due to risk of bias: randomisation and allocation concealment procedures were unclear.
3Downgraded one level due to inconsistency: heterogeneity in analysis.
4Downgraded one level due to uncertainty in outcome measurement.