Summary of findings 1. Intravenous diclofenac compared to placebo for acute postoperative pain in adults.
Intravenous diclofenac (37.5 mg to 75 mg) compared to placebo for acute postoperative pain in adults | ||||||
Patient or population: Adults (mean study ages 25 to 55 years) with acute postoperative pain after dental, mixed minor, abdominal, or orthopedic surgeries Settings: Hospital or community Intervention: Intravenous diclofenac (37.5 mg to 75 mg) Comparison: Placebo | ||||||
Outcomes | Probable outcome with | Relative effect and NNTB or NNTH (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Placebo | Diclofenac | |||||
Number of participants with at least 50% pain relief at 4 hours | 228 per 1000 | 643 per 1000 (458 to 905) |
RR 2.8 (2.0 to 4.0) NNTB 2.4 (1.9 to 3.1) |
277 (3 studies) | ⊕⊕⊝⊝ low1,2,3,4 | |
Number of participants with at least 50% pain relief at 6 hours | 336 per 1000 | 592 per 1000 (478 to 730) |
RR 1.8 (1.4 to 2.2) NNTB 3.8 (2.9 to 5.9) |
436 (4 studies) | ⊕⊕⊝⊝ low1,2 | |
Median (or mean) time to use of rescue medication | Median: 80 minutes | Median: 226 minutes | Not applicable | 542 (5 studies) |
⊕⊕⊝⊝ low1,5 | |
Number of participants using rescue medication over 4 to 6 hours postinterventions | 810 per 1000 | 478 per 1000 (389 to 592) |
RR 0.59 (0.48 to 0.73) NNTp3.0 (2.2 to 4.5) |
235 (2 studies) | ⊕⊕⊝⊝ low1,3 | |
Number of participants reporting any adverse event | 709 per 1000 | 702 per 1000 (610 to 809) | RR 0.99 (0.86 to 1.1) | 296 (2 studies) | ⊕⊕⊝⊝ low1,3 | |
Number of participants experiencing a serious adverse event | 4 per 1000 | 4 per 1000 (1 to 31) | RR 1.0 (0.15 to 7.02) | 472 (5 studies) | ⊕⊕⊝⊝ low1,6 | Studies underpowered to detect these events. |
CI: confidence interval; NNTB: number needed to treat for an additional beneficial outcome; NNTH: number needed to treat for an additional harmful outcome; NNTp: number needed to treat to prevent one event; RR: risk ratio | ||||||
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. |
1Unclear risk of bias in several domains. 2Unexplained heterogeneity. 3Total number of participants < 400. 4Large magnitude of effect: RR > 2. 5Imprecision: unable to estimate confidence intervals due to reporting of median data. 6Very low number of events.