Summary of findings 2. Opioids compared to other analgesics and sedatives for neonates receiving mechanical ventilation.
| Opioids compared to other analgesics and sedatives for neonates receiving mechanical ventilation | ||||||
| Patient or population: neonates receiving mechanical ventilation Setting: neonatal intensive care unit (Anand 1999 multi‐centre study in USA, UK, Germany, Sweden) Intervention: morphine Comparison: midazolam | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | №. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with other analgesics and sedatives | Risk with opioids | |||||
| Pain (PIPP) | Mean pain (PIPP) was 8.9 points | MD 1 points lower (2.66 lower to 0.66 higher) | Mean 8.9 | 46 (1 RCT) | ⊕⊝⊝⊝ VERY LOW | Serious imprecision of the estimatesa and indirectness |
| Duration of mechanical ventilation (days) | Mean duration of mechanical ventilation (days) was 14.2 days | MD 6.7 days lower (12.4 lower to 1 lower) | Mean 14.2 | 46 (1 RCT) | ⊕⊝⊝⊝ VERY LOW | Serious imprecision of the estimatesa and indirectness |
| Neonatal mortality | Study population | RR 0.31 (0.01 to 7.16) | 46 (1 RCT) | ⊕⊝⊝⊝ VERY LOW | Serious imprecision of the estimatesa and indirectness | |
| 45 per 1000 | 14 per 1000 (0 to 325) | |||||
| Mortality before discharge | See comment | See comment | Not estimable | Not reported | Not estimable | None of the studies reported on this outcome |
| Neurodevelopmental outcomes (18 to 24 months) | See comment | See comment | Not estimable | Not reported | Not estimable | None of the studies reported on this outcome |
| Neurodevelopmental outcomes (3 to 5 years) | See comment | See comment | Not estimable | Not reported | Not estimable | None of the studies reported on this outcome |
| Neurodevelopmental outcomes (5 to 6 years) | See comment | See comment | Not estimable | Not reported | Not estimable | None of the studies reported on this outcome |
| *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; PIPP: Premature Infant Pain Profile; MD: mean difference; RCT: randomised controlled trial; 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. | ||||||
aFor "serious imprecision", downgraded by two levels.