OBJECTIVE: To compare the efficacy of nebulized fentanyl (NF) with i.v. morphine (IVM) in paediatric patients presenting to the ED with clinically suspected limb fractures. METHODS: A convenience sample of patients aged 4-13 years, presenting with clinically suspected limb fractures, were randomized to receive either NF at 4 microg/kg or IVM at 0.1 mg/kg. Pain scores were assessed at 0, 15 and 30 min using the Wong and Baker faces pain scale (0-10). Vital signs and adverse effects were also recorded. RESULTS: Of the 77 patients enrolled in the study, data were available for analysis on 73 patients. Of those, 36 received NF and 37 received IVM. The two groups were similar in terms of demographics and initial pain scores. Mean pain score at 15 min was decreased by 3.06 (NF) and by 1.97 (IVM) (difference 1.09; 95% CI 2.32 to -0.32). At 30 min the decreases were 3.6 (NF) and 3.0 (IVM), respectively (difference 0.6; 95% CI 1.89 to -0.65). Decreases in pain scores for both NF and IVM were statistically significant (P < 0.0001), but the difference in the effect of NF and IVM did not reach statistical significance. There was no significant change in any vital signs or serious adverse events in either group. CONCLUSION: NF in a dose of 4 microg/kg given via a standard nebulizer provided clinically significant improvements in pain scores, comparable to IVM. NF should be considered as a treatment option for use in children presenting in acute pain.
RCT Entities:
OBJECTIVE: To compare the efficacy of nebulized fentanyl (NF) with i.v. morphine (IVM) in paediatric patients presenting to the ED with clinically suspected limb fractures. METHODS: A convenience sample of patients aged 4-13 years, presenting with clinically suspected limb fractures, were randomized to receive either NF at 4 microg/kg or IVM at 0.1 mg/kg. Pain scores were assessed at 0, 15 and 30 min using the Wong and Baker faces pain scale (0-10). Vital signs and adverse effects were also recorded. RESULTS: Of the 77 patients enrolled in the study, data were available for analysis on 73 patients. Of those, 36 received NF and 37 received IVM. The two groups were similar in terms of demographics and initial pain scores. Mean pain score at 15 min was decreased by 3.06 (NF) and by 1.97 (IVM) (difference 1.09; 95% CI 2.32 to -0.32). At 30 min the decreases were 3.6 (NF) and 3.0 (IVM), respectively (difference 0.6; 95% CI 1.89 to -0.65). Decreases in pain scores for both NF and IVM were statistically significant (P < 0.0001), but the difference in the effect of NF and IVM did not reach statistical significance. There was no significant change in any vital signs or serious adverse events in either group. CONCLUSION: NF in a dose of 4 microg/kg given via a standard nebulizer provided clinically significant improvements in pain scores, comparable to IVM. NF should be considered as a treatment option for use in children presenting in acute pain.
Authors: David Häske; Bernd W Böttiger; Bertil Bouillon; Matthias Fischer; Gernot Gaier; Bernhard Gliwitzky; Matthias Helm; Peter Hilbert-Carius; Björn Hossfeld; Christoph Meisner; Benjamin Schempf; Arasch Wafaisade; Michael Bernhard Journal: Dtsch Arztebl Int Date: 2017-11-17 Impact factor: 5.594