for the main comparison.
| Paracetamol compared with control for pain | ||||||
|
Patient or population: Neonates Settings: Any Intervention: Paracetamol Comparison: Control | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| [control] | Paracetamol | |||||
| Heel lance ‐ paracetamol (oral) compared to sterile water (oral) for prevention or treatment of pain in newborns | ||||||
| PIPP score (difference between baseline and heel lance period) | The mean PIPP score (difference between baseline and heel lance period) in the intervention groups was 1.4 higher (0.45 lower to 3.25 higher) | 72 (1) | ⊕⊕⊝⊝ low | Bias: there was low risk of bias in this study (see RoB tables) Consistency: N/A as there was only one study included Precision: there was low precision in the point estimate with a wide 95% CI Directness of the evidence: the trial was conducted in the target population Presence of publication bias: N/A as there was only one study included | ||
| Duration of crying (seconds) during the first 3 minutes | The mean duration of crying (seconds) during the first 3 minutes in the intervention groups was 8.1 higher (19.09 lower to 35.29 higher) | 72 (1) | ⊕⊕⊝⊝ low | Bias: there was low risk of bias in this study (see RoB tables) Consistency: N/A as there was only one study included Precision: there was low precision in the point estimate with a wide 95% CI Directness of the evidence: the trial was conducted in the target population Presence of publication bias: N/A as there was only one study included | ||
| Heel lance ‐ paracetamol (oral) compared to glucose (oral) for prevention or treatment of pain in newborns | ||||||
| PIPP (maximum score within 3 minutes following lancing) | The mean PIPP (maximum score within 3 minutes following lancing) in the intervention groups was 2.21 higher (0.72 to 3.7 higher) | 38 (1) | ⊕⊕⊝⊝ low | Bias: there was some concern about selection bias in this study (see RoB tables) Consistency: N/A as there was only one study included Precision: there was low precision in the point estimate with a wide 95% CI Directness of the evidence: the trial was conducted in the target population Presence of publication bias: N/A as there was only one study included | ||
| Heel lance ‐ paracetamol (oral) compared to EMLA (cream) for prevention or treatment of pain in newborns | ||||||
| PIPP (maximum score within 3 minutes following lancing) | The mean PIPP (maximum score within 3 minutes following lancing) in the intervention groups was 1.21 higher (0.38 lower to 2.8 higher) | 38 (1) | ⊕⊕⊝⊝ low | Bias: there was some concern about selection bias in this study (see RoB tables) Consistency: N/A as there was only one study included Precision: there was low precision in the point estimate with a wide 95% CI Directness of the evidence: the trial was conducted in the target population Presence of publication bias: N/A as there was only one study included | ||
| Eye examination ‐ paracetamol (oral) compared to placebo (sterile water) for eye examination for prevention or treatment of pain in newborns | ||||||
| PIPP score in first 45 seconds of eye examination | The mean PIPP score in first 45 seconds of eye examination in the intervention groups was 0.8 lower (1.69 lower to 0.09 higher) | 80 (1) | ⊕⊕⊝⊝ low | Bias: there was some concern about performance bias in this study (see RoB tables) Consistency: N/A as there was only one study included Precision: there was low precision in the point estimate with a wide 95% CI Directness of the evidence: the trial was conducted in the target population Presence of publication bias: N/A as there was only one study included | ||
| Eye examination ‐ paracetamol (oral) compared to 24% sucrose (oral) for prevention or treatment of pain in newborns | ||||||
| PIPP score in first 45 seconds of eye examination | The mean PIPP score in first 45 seconds of eye examination in the intervention groups was 3.9 higher (2.92 to 4.88 higher) | 81 (1) | ⊕⊕⊝⊝ low | Bias: there was some concern about performance bias in this study (see RoB tables) Consistency: N/A as there was only one study included Precision: there was low precision in the point estimate with a wide 95% CI Directness of the evidence: the trial was conducted in the target population Presence of publication bias: N/A as there was only one study included | ||
| Eye examination ‐ paracetamol compared to morphine for prevention or treatment of pain in newborns | ||||||
| PIPP score 5 minutes after eye examination | The mean PIPP score 5 minutes after eye examination in the intervention groups was 1.1 higher (0.7 lower to 2.9 higher) | 11 (1) | ⊕⊝⊝⊝ Very low |
Bias: there was low risk of bias in this study (see RoB tables) Consistency: N/A as there was only one study included Precision: there was low precision in the point estimate with a wide 95% CI. Only 11 infants were included in the analysis Directness of the evidence: the trial was conducted in the target population Presence of publication bias: N/A as there was only one study included | ||
| *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; RoB: Risk of bias | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: 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 quality: We are very uncertain about the estimate. | ||||||