Role of midazolam and its oral formulation for diagnostic and therapeutic procedures in paediatric medicine

Autori: C. Del Corno, S. Di Matteo, G.M. Bruno, C. Martinotti, G.L. Colombo

In paediatric medicine, pharmacological sedation for diagnostic and therapeutic procedures and as premedication before the induction of anaesthesia is a topic of interest and discussion, due to the presence of still unmet medical needs. The use of midazolam as pre-anaesthetic or in the procedural analgosedation in paediatric patients is well established and considered safe and effective. However, at the moment, in Italy, the only authorised formulation of midazolam is by injection, to which the refusal by paediatric patients is commonly reported, requiring additional actions to complete the programmed or emergency procedures. Moreover, in hospital, the off-label use of extemporaneous oral solutions of midazolam (IV and IM vials) in paediatric patients is also well-documented. Also in this case the success of the therapy may be hindered by the bitter taste of the medication, leading to drug rejection by the patient or to its poor collaboration. Aiming at collecting data from current clinical practice in Italy, we created a survey in order to obtain specific information about paediatric analgosedation and about the methods and difficulties of administering sedative drugs for diagnostic/therapeutic procedure or as pre-anaesthetic agents. The survey, consisting of 10 questions, was administered from February to July 2020 to Italian clinicians of 19 centres located throughout the country. The results of the survey, containing the information of 2,255 patients, highlighted the presence of unmet medical needs for these patients, linked to the difficulties in the drug administration and the lack of an authorised oral formulation of midazolam for paediatric use. In particular, results showed that 1,732 (77%) subjects were treated for pre-anaesthesia and 523 (23%) for procedural intervention. Among the patients treated for pre-anaesthesia, 801 were treated for sedation (325 <6 years and 476 >6 years) and 931 for anxiolysis (329 <6 years and 602 >6 years). Among the patients treated for procedural sedation (523), 369 were treated for a programmed elective intervention, while the remaining 154 were treated in emergency. The results concerning the difficulty/delay in the administration of midazolam, reported in 47% of cases, were of interest. As a matter of fact, according to the results, due to the difficulties in the administration of the drug, in 39% of cases the intervention was postponed, in 32% of cases the therapy was changed and in the remaining 29% of cases a non-pharmacological action was adopted. Ultimately, the results of the survey showed the presence of important unmet medical needs related to issues in the drug administration and the lack of an authorised oral formulation for paediatric use. These conditions make it necessary the off-label use of extemporaneous oral formulations of midazolam with the favourable opinion of clinicians towards the administration of an oral formulation specifically authorised for paediatric use. The availability of such medication would respond to important unmet medical needs, representing an effective, appropriate and well tolerated therapeutic alternative for moderate sedation before diagnostic and therapeutic procedures and as premedication before the induction of anaesthesia in paediatric patients.

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