Summary of findings 2. Opioids compared to oral sweet solution or non‐pharmacological intervention for procedural pain in neonates.
| Opioids compared to oral sweet solution or non‐pharmacological intervention for procedural pain in neonates | ||||||
| Patient or population: neonates exposed to procedural pain Setting: neonatal units Intervention: opioids Comparison: oral sweet solution or non‐pharmacological intervention | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with oral sweet solution or non‐pharmacological intervention | Risk with opioids | |||||
| Pain, assessed using the CRIES pain scale, ranging from 0 to 10, during the procedure— opioids versus facilitated tucking | Mean CRIES—opioids versus facilitated tucking was 9. | MD 4.62 lower (6.38 lower to 2.86 lower) | ‐ | 100 (1 RCT) | ⊕⊝⊝⊝ Very low 1 | The evidence is very uncertain about the effect of opioids on pain score assessed with the CRIES scale during the procedure compared to facilitated tucking. |
| Pain, assessed using the CRIES pain scale, ranging from 0 to 10, during the procedure— opioids versus sensorial stimulation | Mean CRIES—opioids versus sensorial stimulation was 4. | MD 0.32 higher (1.13 lower to 1.77 higher) | ‐ | 100 (1 RCT) | ⊕⊝⊝⊝ Very low 1 | The evidence is very uncertain about the effect of opioids on pain score assessed with the CRIES scale during the procedure compared to sensorial stimulation. |
| Any harms | ‐ | ‐ | ‐ | ‐ | ‐ | This outcome was not reported. |
| Episodes of bradycardia—not reported | ‐ | ‐ | ‐ | ‐ | ‐ | This outcome was not reported. |
| Episodes of apnea—not reported | ‐ | ‐ | ‐ | ‐ | ‐ | This outcome was not reported. |
| Hypotension—not reported | ‐ | ‐ | ‐ | ‐ | ‐ | This outcome was not reported. |
| Parent satisfaction with care provided in the NICU—not reported | ‐ | ‐ | ‐ | ‐ | ‐ | This outcome was not reported. |
| *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; CRIES: Crying Requires oxygen Increased vital signs Expression Sleep; MD: mean difference; NICU: neonatal intensive care unit; RCT: randomized controlled trial | ||||||
| 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. | ||||||
1Downgraded two levels for study limitations (high risk of performance bias; unclear risk of bias for the other domains) and one level for imprecision (one small trial with low sample size; CIs overlapping no effect).