Midazolam Hydrochloride

Emergence delirium (ED) was first described by Eckenhoff and colleagues in the 1960s (Eckenhoff et al., 1961) and is defined in pediatric anesthesia as 'dissociated state of consciousness in which child is irritable, uncompromising, uncooperative, incoherent, and inconsolably crying, moaning, and kicking or thrashing (Vlajkovic and Sindjelic, 2007). The commonly reported incidence of postoperative ED in pediatric patients especially with the use of sevoflurane or desflurane was from 10% to 80% during their presence in the post-anesthesia care unit (Dahmani et al., 2010), (Doerrfuss et al., 2019), (Menser and Smith, 2020) and (Shin et al., 2021). This side effect of general anesthesia causes distressing for parents and staff and may cause parental dissatisfaction with their child's care (Bong et al., 2015). Children during postoperative ED have the risks of injuring themselves or their caregivers, disruption of surgical repair, operative site bleeding, removing Intravenous (iv) lines or drains and increasing pain. This behavior may require more nursing supervision, overloading nursing resources (Mountain et al., 2011). Although postoperative ED episodes are of short duration, their prevention is essential. Children experiencing postoperative ED may exhibit new-onset maladaptive behavioral abnormalities in the postoperative period such as enuresis, night-time crying, and separation anxiety, up to 14 days post-surgery (Kain et al., 2004). The risk factors to postoperative ED are patients' characters (preschool age and preexisting behavior), the surrounding environment as parental anxiety, type of anesthesia (volatile anesthetics) as sevoflurane or halothane and the type of surgery as tonsillectomy, adenoidectomy, and strabismus surgery (Aono et al. 1997 and Cravero et al, 2000) which is one of the most commonly undertaken surgeries in pediatric patients. It may cause visual disturbance in the recovery phase, which can result in ED (Voepel et al., 2003). In order to diagnose ED, the presence of pain during recovery from general anesthesia must be ruled out because it leads to a change in behavior that resembles delirium. Fortunately, one of the advantages of using the Pediatric Anesthesia Emergence Delirium (PAED) scale is its ability to distinguish between the ED and the change in behavior resulting from pain, because it focuses on changes in awareness and knowledge that are not changed by pain (Sikich and Lerman, 2004). Prophylactic drugs against the occurrence of postoperative ED include the adjuvant use of α2 adrenoreceptor agonists such as dexmedetomidine, ketamine, midazolam, propofol, and fentanyl. The use of these drugs with them adverse effects should be weighed against the fact that postoperative ED is a self-limited disorder (Dahmani et al., 2010), (Kim et al., 2011), (Reduque and Verghese, 2012), (Mason, 2017) and (Wang et al., 2021). Dexmedetomidine is a highly selective α2-adrenergic receptor agonist that is associated with sedative and analgesic sparing effects. It is commonly used for prevention of emergence delirium and agitation, perioperative sympatholysis, cardiovascular stabilization, and preservation of respiratory function (Fang et al., 2016), (Elghamry & Elkeblawy, 2021), (Abdelzaam
& Mahdy, 2020) and ( Yao et al., 2020). Ketamine is a dissociative anesthetic. Its mechanism of action is mainly via a noncompetitive antagonism of the N - methyl - D - aspartic acid (NMDA) receptor. It also targets other receptors, such as a - amino - 3 - hydroxy - 5 - methyl - 4 - isoxazolepropionic acid (AMPA) receptors, and has additional acts as an agonist of the sigma 1 receptor. It is commonly used for acute pain management, chronic pain management, prevention of ED, and postoperative nausea and vomiting (Fang et al., 2016) and (Abdelzaam & Mahdy, 2020). Midazolam is short acting benzodiazepine which is central nervous system depressant. It is commonly used for premedication during pediatric anesthesia, for prevention of emotional distress and ED due to its sedative and anxiolytic properties, additionally it used for reduction of the analgesic requirement and to prevent postoperative nausea and vomiting

This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. Patients will be randomized to one of two groups by block randomization.