A paediatric trial comparing midazolam/Syrpalta mixture with premixed midazolam syrup (Roche)

Background: The bitter taste of midazolam is more acceptable to children when the drug is mixed with fruit juice or syrup. We use a thick grape syrup (Syrpalta), and children are sedated in 10-15 min. A premixed cherry-flavoured midazolam solution (Roche), 2 mg.ml(-1), is currently available. It has been our impression that the premixed midazolam has a slower onset of action. Our aim was to evaluate the effects of the midazolam mixtures (midazolam 0.5 mg.kg(-1), 2 mg.ml(-1)) on children's anxiety, sedation, separation anxiety, mask acceptance, and recovery time. Methods: Seventy-six healthy children, 1-4 years of age, scheduled for elective placement of ear tubes, were enrolled. The trial was double-blinded and randomized. For premedication, one group received the premixed midazolam, and a second group received the midazolam/Syrpalta mixture. An independent blinded observer evaluated the children, using anxiety and sedation scales at baseline, at 5, 10 and 15 min and at parental separation. Mask acceptance and awakening time were evaluated. Results: Children who received the midazolam/Syrpalta mixture had less anxiety at 15 min (P = 0.046) and at parental separation (P < 0.001) than those who received the premixed midazolam solution. Mask acceptance was not different. Conclusions: We concluded that the midazolam/Syrpalta mixture has a faster onset of action than the premixed midazolam solution.