Purpose: To investigate the tolerability of midazolam intravenous (IV) solution by masking its bitter taste through the addition of syrup.
Methods: In the waiting area before surgery at our institution, Eye and ENT Hospital, from May to November of 2021, pediatric patients scheduled for anterior ear fistula removal or eardrum catheterization were randomly assigned to receive a mixture of IV midazolam and water (Group C) or IV midazolam and syrup (Group S) in equal volumes. We measured the difference between the groups in terms of drug tolerability with a 5-point facial hedonic scale given to every patient, parent, and nurse involved in the study. Secondary outcomes included sedation and anxiety levels, which were assessed at separation from the parents and general anesthesia induction via a mask.
Results: In total, 180 patients were enrolled. The facial hedonic scales were higher in Group S as evaluated by the children (p=0.046), parents (p=0.020), and nurses (p=0.026). More patients were willing to take the same solution again in Group S than in Group C (p=0.024). The levels of sedation and anxiety at two timepoints were similar between the groups (all p> 0.05). No adverse events were noted preoperatively.
Conclusion: The tolerability of IV midazolam administered orally was increased in a pediatric population by adding syrup. The sedative and anxiolytic effects were comparable for both midazolam mixtures.
Trial Registry Number: China Clinical Research Information Service, ChiCTR2000040229.
Keywords: oral midazolam, pediatric preoperative sedation, pediatric preoperative anxiety