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. 2016 Apr 13;2016(4):CD011131. doi: 10.1002/14651858.CD011131.pub2

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.