Aim: To compare the efficacy of sublingual midazolam with oral morphine versus that of oral morphine with placebo in a paediatric population attending an emergency department (ED) with acute long-bone fractures.
Methods: A sample of children aged 5-16 years with clinically deformed closed long-bone fractures was randomized to groups receiving either oral morphine (0.5 mg/kg)/sublingual placebo or oral morphine (0.5 mg/kg)/sublingual midazolam (0.2 mg/kg). The main exclusion criteria were narcotic or benzodiazepine use, significant head injury, multiple organ failure, femoral fracture and allergy. Pain scores were rated on a 100-mm visual analogue scale (VAS) at 0, 15, 30, 60, 90 and 120 min.
Results: Fifty-eight children were enrolled (mean age: 10.5 years, SD 2.7). Fractures concerned the radius or ulna in 43 cases (74.1%), the humerus (22.4%) and the tibia or fibula (3.5%). No significant difference in VAS scores was observed between the two treatment arms (p = 0.72). Drowsiness was significantly more frequent in the midazolam group (p = 0.007) during the first 2 h after administration. No serious adverse event was observed.
Conclusion: The analgesic performances of morphine and the combination of morphine with midazolam assessed by VAS were similar in children presenting at the ED with a long-bone fracture.
Trial registration: ClinicalTrials.gov NCT00416039.
© 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.