Comparison of the effect of intravenous ketamine and midazolam as a premedication in children undergoing cochlear implantation at the time of separation from parents

Abasali Delavari¹, Seyed J. Madani¹, Abbas Rahmani¹, Marzieh Lak^{1,* ✉}

1 - Trauma research center, Baqiyatallah University of Medical Sciences, Tehran, Iran 297 emergence agitation, restlessness, disorientation, and anxiety in children [5, 6]. Deaf-muteness children like healthy children recognize environmental events and preoperative anxiety and the fear of separation from parents are some of the most important preoperative problems for these children [5, 7]. Therefore, sedation or premedication is often needed for deaf-muteness children during their separation from parents and entrance to the waiting room. Midazolam and ketamine are commonly used as premedication in children undergoing medical procedures [8]. Midazolam is an imidazole benzodiazepine that has depressant effects on the central nervous system and provides sedation, muscle relaxation, and amnesia before procedures [9, 10]. It has a rapid onset of action following oral, rectal administration [10]. A great number of studies have used midazolam as a safe premedication without any serious adverse effects for sedation of children during procedures [11, 12]. It has been also shown that preoperative oral midazolam reduces separation anxiety and emergence agitation in children following anesthesia [6]. intramuscular, nasal, and intravenous, Its [13]. in children Ketamine is a general anesthetic with sedative and analgesic properties which is commonly used as a premedication for favorable effects on sedation cardiovascular and pulmonary parameters are a reason by which physicians use this drug as a sedative [14, 15]. Therefore, these data indicated that both midazolam and ketamine are safe effective sedative premedication agents which can be used in children undergoing painful producers [16]. Although many studies have investigated the effect of midazolam and ketamine for sedation of children following medical surgery, no study evaluated the preoperative effect of these drugs on sedation in children with hearing loss and deaf mutism. Therefore, we designed this study, for the first time, to compare the preoperative effect of midazolam and ketamine as premedication on sedation in deaf-mutism children during their separation from parents and before cochlear implantation. PATIENTS AND METHODS Patients This double-blinded, prospective clinical trial study was conducted on 74 children with deaf-muteness who were referred to Baqiyatallah Hospital for cochlear implantation from June 2019 to November 2019. This study was registered in the Iranian Registry of Clinical Trials under no. IRCT20161022030421N3 cod. The protocol of the study was confirmed by the ethics committee of Sciences Baqiyatallah University Medical of 298 (IR.BMSU.REC.1397.031). Written informed consents were signed by all parents. A questionnaire containing demographic data of all patients (e.g. age, sex, weight, and history of any previous illness) was

Correspondence: Marzieh Lak

Received: December 2, 2020

Accepted: March 14, 2021

Abstract:

Background and aim: Preoperative anxiety and fear of separation from parents are some of the most important preoperative problems for children with deaf muteness. Here, the effect of intravenous administration of ketamine and midazolam was compared on sedation in children who candidates for choral cochlear implantation at the time of separation from parents. Patients and methods: This double-blind, prospective clinical study was performed on 74 children with deaf-muteness before cochlear implantation. Patients were randomly divided into two groups, midazolam (0.1 mg /kg) and ketamine (1 mg/kg). The sedation anxiety score scale (SASS) form was filled in to assess the anxiety and sedation status for each child. The children’s relaxation score from recovery was assessed by the PACU sedation score scale (PACUSSS). Results: The average of the children’s anxiety score after the injection of both drugs during the separation from their parents was 3, and there was no significant difference in the mean of SASS between the two groups (p>0.05). The mean PACU sedation score scale in both ketamine and midazolam groups was 1.08 ± 0.89 and 1.32 ± 1.01, respectively (p = 0.27). The mean of extubation and recovery times in the ketamine group were 10.44 ± 4.47 and 30.27 ± 6.87, respectively, while the mean extubation and recovery times in the midazolam group were 11.83 ± 3.33 and 29.81 ± 6.31 minutes, respectively. Conclusion: Both ketamine and midazolam caused equal sedation scores in children with deaf muteness at the time of separating from their parents.