| Intranasal fentanyl compared with intravenous morphine for the management of acute moderate to severe pain in children |
| Patient or population: children (aged < 18 years) with acute severe pain Settings: emergency department Intervention: intranasal fentanyl Comparison: intravenous morphine |
| Pain reduction (mean VAS) Pain assessed before analgesia (0 min) and at 5, 10, 20 and 30 min after analgesia | 0 min = 67 5 min = 42 10 min = 41 20 min = 35 30 min = 33 | 0 min = 68 5 min = 55 10 min = 46 20 min = 37 30 min = 37 | | 67 participants (1 study) | ⊕⊕⊕⊕
high | Given no statistically significant difference between treatment arms, VAS scores were combined to form an overall VAS score for each time point. Combined VAS scores produced statistically significant reductions in pain at 5, 10 and 20 min after analgesia |
| Respiratory depression | No cases were reported in this study | No cases were reported in this study | | 67 participants (1 study) | ⊕⊕⊕
moderate | Dosage regimen for this study was calculated for 3 weight intervals. Inclusion of 21 children outside the weight intervals (1 less than 20 kg and 20 greater than
50 kg) may have resulted in most of these children receiving smaller per‐kilogram doses of IV morphine and INF, thereby reducing the potential occurrence of adverse events listed |
| Hypotension | No cases were reported in this study | No cases were reported in this study | | 67 participants (1 study) | ⊕⊕⊕
moderate | Dosage regimen for this study was calculated for 3 weight intervals. Inclusion of 21 children outside the weight intervals (1 less than 20 kg and 20 greater than
50 kg) may have resulted in most of these children receiving smaller per‐kilogram doses of IV morphine and INF, thereby reducing the potential occurrence of adverse events listed |
| Decreased level of consciousness | No cases were reported in this study | No cases were reported in this study | | 67 participants (1 study) | ⊕⊕⊕
moderate | Dosage regimen for this study was calculated for 3 weight intervals. Inclusion of 21 children outside the weight intervals (1 less than 20 kg and 20 greater than
50 kg) may have resulted in most of these children receiving smaller per‐kilogram doses of IV morphine and INF, thereby reducing the potential occurrence of adverse events listed |
| Intolerance to analgesia | 1 participant complained of a momentary flush at the IV site following administration of morphine | 4 participants; 3 participants reported a "bad taste" following INF administration, 1 participant vomited 20 min following INF administration | | 67 participants (1 study) | ⊕⊕⊕⊕
high | |
| Use of ED "rescue" analgesia | 1 participant required 5 additional doses of IV morphine (protocol violation) | 1 participant required 6 additional doses of INF (protocol violation) | | 67 participants (1 study) | ⊕⊕⊕
moderate | Protocol violation in control and intervention arms of this trial. As per protocol, participants should receive only 4 additional doses of either agent |
| *The basis for the assumed risk (e.g. 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; RR: Risk ratio. |
| 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. |
