Table 6.
Certainty assessment | No. of patients | Effect | Certainty | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Outcomes | No. of studies | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Opioid | Non-opioid | Relative (95% CI) | Absolute (95% CI) | |
Need for rescue analgesia | 6 RCTs | seriousb, c, e | seriousd | not serious | not serious | strong association | 60/183 (32.8%) |
110/185 (59.5%) |
OR 0.25 (0.07 to 0.86) | 326 fewer per 1,000 (from 501 fewer to 37 fewer) | ⊕⊕⊕◯ MODERATE |
ΔVAS within 24 h (follow up: 0.5 h to 24 h) | 4 RCTs | seriousb, c | serious a, d | not serious | not serious | none | 109 | 139 | - | MD 6.06 higher (18.10 lower to 30.22 higher) |
⊕⊕◯◯ LOW |
Any complication | 5 RCTs | seriousb, c, e | serious d, f | not serious | not serious | none | 59/123 (48.0%) |
59/125 (47.2%) |
OR 1.16 (0.61 to 2.20) |
37 more per 1,000 (from 119 fewer to 191 more) | ⊕⊕◯◯ LOW |
Length of hospital stay | 2 RCTs | seriouse | seriousd | not serious | not serious | none | 42 | 46 | - | MD 3.03 lower (7.34 lower to 1.2 higher) | ⊕⊕◯◯ LOW |
Adverse events | 5 RCTs | seriousb, c, e | seriousd | not serious | not serious | none | 18/162 (11.1%) |
14/165 (8.5%) |
OR 1.52 (0.55 to 4.21) |
37 more per 1,000 (from 35 fewer to 191 more) | ⊕⊕◯◯ LOW |
CI, confidence interval; RCT, randomised controlled trial; VAS, visual analogue scale; MD, mean difference; OR, odds ratio.
Variation of time points for pain scoring.
Unblinded of study by Kahl et al. (40).
Unblinded of study by Peiro et al. (43).
Variation of dose and approach for drug administration.
Unblinded of study by Jakobs et al. (39).
Definitions of complications of acute pancreatitis were not consistent across different studies. GRADE levels of quality of evidence: High, further research is very unlikely to change our confidence in the estimate of effect; Moderate, further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate; Low, 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, any estimate of effect is very uncertain.