Summary of findings 1. NSAID compared to placebo in women undergoing breast surgery.
| NSAID compared to placebo in women undergoing breast surgery | |||||||
| Patient or population: women undergoing breast surgery Setting: inpatient and outpatient Intervention: NSAID Comparison: placebo | |||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments: types of NSAIDs | ||
| Risk with placebo | Risk with NSAID | ||||||
| Incidence of breast hematoma | 35 per 1000 | 12 per 1000 (2 to 71) | RR 0.33 (0.05 to 2.02) | 230 (2 RCTs) |
⊕⊕⊝⊝ Lowa,b,c,g |
parecoxib, celecoxib | |
| Preoperative | 15 per 1000 | 15 per 1000 (1 to 230) | RR 1.00 (0.06 to 15.66) |
136 (1 RCT) | ⊕⊕⊝⊝ Lowa,g,h | parecoxib | |
| Pain intensity 24 (± 12) hours following surgery | The mean pain intensity 24 (± 12) hours following surgery ‐ perioperative was 0 | SMD 0.26 lower (0.49 lower to 0.03 lower) | ‐ | 310 (3 RCTs) | ⊕⊕⊝⊝ Lowa,b,c,d,e,j | ketorolac, diclofenac | |
| Preoperative | The mean pain intensity 24 (± 12) hours following surgery ‐ preoperative was 0 | SMD 0.19 lower (0.46 lower to 0.09 higher) | ‐ | 202 (1 RCT) | ⊕⊕⊝⊝ Lowb,h | ketorolac | |
| Postoperative | The mean pain intensity 24 (± 12) hours following surgery ‐ postoperative was 0 | SMD 0.04 higher (0.50 lower to 0.57 higher) | ‐ | 60 (1 RCT) | ⊕⊝⊝⊝ Very lowa,c,d,e,h,i |
ketorolac | |
| Incidence rate or severity of postoperative nausea, vomiting, or both | 111 per 1000 | 128 per 1000 (64 to 252) | RR 1.15 (0.58 to 2.27) |
939 (4 RCTs) |
⊕⊕⊝⊝ Lowa,b,c,d,e,i,k | ketorolac, diclofenac, celecoxib, parecoxib | |
| Preoperative | 60 per 1000 | 177 per 1000 (25 to 1000) | RR 2.95 (0.42 to 20.64) |
831 (2 RCTs) | ⊕⊝⊝⊝ Very lowa,b,c,e,f,i,j |
celecoxib, parecoxib | |
| Postoperative | 700 per 1000 | 399 per 1000 (252 to 644) | RR 0.57 (0.36 to 0.92) |
60 (1 RCT) | ⊕⊝⊝⊝ Very lowa,c,d,e,i | ketorolac | |
| Bleeding from any location within 90 days | 169 per 1000 | 178 per 1,000 (151 to 210) | RR 1.05 (0.89 to 1.24) |
251 (2 RCT) | ⊕⊕⊝⊝ LOWa,b,g | ketorolac, diclofenac | |
| Preoperative | 0 per 1000 | 0 per 1000 (0 to 0) | RR 3.34 (0.14 to 81.03) |
203 (1 RCT) |
⊕⊝⊝⊝ Very lowb,g,h | ketorolac | |
| Need for blood transfusion | 0 per 1000 | 0 per 1000 (0 to 0) | RR 4.62 (0.23 to 91.34) |
48 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b,g,i | diclofenac | |
| Preoperative | 0 per 1000 | 0 per 1000 (0 to 0) | RR 4.62 (0.23 to 91.34) |
48 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b,g,i | diclofenac | |
| Other side effects of NSAID use | 62 per 1000 | 69 per 1000 (27 to 176) | RR 1.12 (0.44 to 2.86) |
251 (2 RCTs) |
⊕⊕⊝⊝ Lowa,b,g | ketorolac, diclofenac | |
| Preoperative | 65 per 1000 | 83 per 1000 (31 to 221) | RR 1.27 (0.48 to 3.38) |
203 (1 RCT) | ⊕⊕⊝⊝ Lowb,h | ketorolac | |
| Opioid use within 24 (± 12) hours of surgery | The mean opioid use within 24 (± 12) hours of surgery ‐ preoperative was 0 | SMD 0.45 lower (0.85 lower to 0.05 lower) | ‐ | 304 (4 RCTs) |
⊕⊕⊝⊝ Lowa,b,c,d,e,j | ketorolac, diclofenac, parecoxib, flurbiprofen | |
| Preoperative | The mean opioid use within 24 (± 12) hours of surgery ‐ preoperative was 0 | SMD 0.85 lower (1.20 lower to 0.50 lower) | ‐ | 136 (1 RCT) | ⊕⊕⊝⊝ Lowa,h | parecoxib | |
| Postoperative | The mean opioid use within 24 (± 12) hours of surgery ‐ postoperative was 0 | SMD 0.29 lower (0.83 lower to 0.25 higher) | ‐ | 60 (1 RCT) | ⊕⊝⊝⊝ Very lowa,c,d,e,g,h | ketorolac | |
| *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; NSAID: nonsteroidal anti‐inflammatory drug; RCT: randomized controlled trial; RR: risk ratio; SMD: standardised mean difference. | |||||||
| 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. | |||||||
We downgraded by 1 point for ≥ 1 of the following and 2 points for > 4 of the following due to risk of bias.
aUnclear or high risk selective reporting. bUnclear or high risk incomplete outcomes data. cUnclear or high risk allocation concealment. dUnclear or high risk random sequence generation. eUnclear or high risk blinding of outcome assessment. fUnclear or high risk blinding of participants and personnel.
We downgraded by 1 point for each of the following.
gImprecision. hSingle study. iSample < 100 participants. jHeterogeneity > 50%. kHeterogeneity > 75%.