Summary of findings 2. NSAID (single administration, any dose) compared to paracetamol for perineal pain in the early postpartum period.
NSAID (single administration, any dose) compared to paracetamol for perineal pain in the early postpartum period | ||||||
Patient or population: women with perineal pain in the early postpartum period Setting: maternity hospitals in Italy, Spain, USA, France and Thailand Intervention: NSAID (single administration, any dose) Comparison: paracetamol | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Risk with paracetamol | Risk with NSAID (single administration, any dose) | |||||
Adequate pain relief (4 hours after administration) | Study population | RR 1.54 (1.07 to 2.22) | 342 (3 RCTs) | ⊕⊕⊝⊝ lowa,b | ‐ | |
205 per 1000 | 315 per 1000 (219 to 454) | |||||
Adequate pain relief (6 hours after administration) | Study population | RR 1.82 (0.61 to 5.47) | 99 (2 RCTs) | ⊕⊝⊝⊝ very lowa,c | ‐ | |
200 per 1000 | 364 per 1000 (122 to 1000) | |||||
Need for additional analgesia (4 hours after administration) | Study population | RR 0.55 (0.27 to 1.13) | 73 (1 RCT) | ⊕⊝⊝⊝ very lowa,c | ‐ | |
405 per 1000 | 223 per 1000 (109 to 458) | |||||
Need for additional analgesia (6 hours after administration) | Study population | RR 0.28 (0.12 to 0.67) | 59 (1 RCT) | ⊕⊕⊝⊝ lowa,b | ‐ | |
571 per 1000 | 160 per 1000 (69 to 383) | |||||
Maternal drug adverse effects (4 hours after administration) | See comment | not estimable | 210 (1 RCT) | 1 study (210 women) reported no maternal drug adverse events in either the intervention or control group | ||
Maternal drug adverse effects (6 hours after administration) | Study population | RR 0.74 (0.27 to 2.08) | 300 (3 RCTs) | ⊕⊝⊝⊝ very lowa,c | ‐ | |
53 per 1000 | 39 per 1000 (14 to 111) | |||||
Neonatal drug adverse effects ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐‐ | ‐ |
*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; 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 |
aDowngraded one level for serious risk of bias: unclear risk of selection bias. bDowngraded one level for imprecision: few participants. cDowngraded two levels for imprecision: few participants and wide 95% confidence interval consistent with possible benefit and possible harm.