Summary of findings for the main comparison.
NSAID compared with placebo for perineal pain in the early postpartum period
| NSAID compared with placebo for perineal pain in the early postpartum period | ||||||
| Patient or population: women with perineal pain in the early postpartum period Settings: maternity hospitals in the USA, UK, Belgium, Spain, France, Italy, Venezuela, India, Malaysia, Thailand, and Iran. Intervention: NSAID 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 | NSAID | |||||
| Adequate pain relief number of participants with adequate pain relief Follow‐up: 4 hours | 284 per 1000 | 543 per 1000 (466 to 634) | RR 1.91 (1.64 to 2.23) | 1573 (10 studies) | ⊕⊕⊝⊝ low1,2 | |
| Adequate pain relief number of participants with adequate pain relief Follow‐up: 6 hours | 321 per 1000 | 615 per 1000 (542 to 696) | RR 1.92 (1.69 to 2.17) | 2079 (17 studies) | ⊕⊝⊝⊝ very low2,3,4 | |
| Need for additional analgesia number of participants who received additional analgesia Follow‐up: 4 hours | 305 per 1000 | 119 per 1000 (79 to 177) | RR 0.39 (0.26 to 0.58) | 486 (4 studies) | ⊕⊕⊝⊝ low4,5 | |
| Need for additional analgesia number of participants who received additional analgesia Follow‐up: 6 hours | 438 per 1000 | 140 per 1000 (114 to 175) | RR 0.32 (0.26 to 0.40) | 1012 (10 studies) | ⊕⊕⊝⊝ low4,5 | |
| Maternal drug adverse effects number of women experiencing adverse effects Follow‐up: 4 hours | See comment | See comment | Not estimable | 90 (1 study) | ⊕⊕⊝⊝ low6 | One small study reported no maternal drug adverse events in either the intervention or control group |
| Maternal drug adverse effects number of women experiencing adverse effects Follow‐up: 6 hours | 22 per 1000 | 31 per 1000 (16 to 60) | RR 1.38 (0.71 to 2.70) | 1388 (13 studies) | ⊕⊝⊝⊝ very low4,7,8 | |
| Neonatal drug adverse effects | No data | |||||
| *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. | ||||||
1 Downgraded one level due to serious risk of bias: two studies included in this outcome had instances of high risk of bias. The remaining studies had a mix of low and unclear risk of bias 2 Downgraded based on visual inspection of funnel plot which indicates likely publication bias 3 Downgraded two levels due to the serious risk of bias: four studies included in this outcome had instances of high risk of bias. The remaining studies had a mix of low and unclear risk of bias 4 Downgraded one level due to inconsistency resulting from different NSAIDs at different doses included in the overall outcome meta‐analysis 5 Downgraded one level due to serious risk of bias: one study included in this outcome had instances of high risk of bias. The remaining studies had a mix of low and unclear risk of bias.
6 Downgraded two levels due to imprecision ‐ small sample size and no events
7 Downgraded one level due to serious risk of bias: two studies included in this outcome had instances of high risk of bias. The remaining studies had a mix of low and unclear risk of bias. 8 Downgraded one level due to few events and 95% CI around the pooled estimate includes no effect