Summary of findings for the main comparison. Non‐steroidal anti‐inflammatory drugs (NSAID) compared with placebo for painful sickle cell vaso‐occlusive crises.
NSAIDs compared with placebo for painful sickle cell vaso‐occlusive crises | ||||||
Patient or population: adults with sickle cell disease in a vaso‐occlusive crises Settings: emergency departments Intervention: NSAIDs (ketorolac or ketoprofen) Comparison: placebo | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Placebo | NSAIDs | |||||
Participant‐reported pain relief of 50% or greater | No data | No data | No data | No data | No dataa | Quality of the evidence is unknown |
Participant‐reported pain relief of 30% or greater | No data | No data | No data | No data | No dataa | Quality of the evidence is unknown |
PGIC very much improved (Follow‐up: up to 5 days) |
0/11 | 3/10 | RR 7.64 (0.44 to 131.75) | 21 participants, 21 VOC events (1 study) | ⊕⊝⊝⊝ Very lowb | — |
PGIC much or very much improved (Follow‐up: up to 5 days) |
4/11 | 6/10 | RR 1.65 (0.65 to 4.19) | 21 participants, 21 VOC events (1 study) | ⊕⊝⊝⊝ Very lowb | — |
Any adverse event (Follow‐up: up to 5 days) |
19/45 | 16/45 | N/A | 72 participants, 90 VOC events (2 studies) | ⊕⊝⊝⊝ Very lowb | — |
Serious adverse events (Follow‐up: up to 5 days) |
2/56 | 1/55 | N/A | 93 participants, 111 VOC events (3 studies) | ⊕⊝⊝⊝ Very lowb | — |
Withdrawals due to adverse events (Follow‐up: up to 5 days) |
1/56 | 1/55 | N/A | 93 participants, 111 VOC events (3 studies) | ⊕⊝⊝⊝ Very lowb | — |
*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; N/A: not applicable; NSAID: non‐steroidal anti‐inflammatory drug; PGIC: Patient Global Impression of Change; RR: risk ratio; VOC: vaso‐occlusive crisis. | ||||||
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. |
a No data available, therefore no GRADE rating has been performed for this outcome and the quality of the evidence is unknown.
b Downgraded three levels; too few data (limited number of participants per treatment arm) to have confidence in results.