Postoperative recovery in preschool-aged children: A secondary analysis of a randomized controlled trial comparing premedication with midazolam, clonidine, and dexmedetomidine.

BACKGROUND: Preoperative anxiety in pediatric patients can worsen postoperative outcomes and delay discharge. Drugs aimed at reducing preoperative anxiety and facilitating postoperative recovery are available; however, their effects on postoperative recovery from propofol-remifentanil anesthesia have not been studied in preschool-aged children. Thus, we aimed to investigate the effects of three sedative premedications on postoperative recovery from total intravenous anesthesia in children aged 2-6 years. METHODS: In this prespecified secondary analysis of a double-blinded randomized trial, 90 children scheduled for ear, nose, and throat surgery were randomized (1:1:1) to receive sedative premedication: oral midazolam 0.5 mg/kg, oral clonidine 4 µg/kg, or intranasal dexmedetomidine 2 µg/kg. Using validated instruments, outcome measures including time for readiness to discharge from the postoperative care unit, postoperative sedation, emergence delirium, anxiety, pain, and nausea/vomiting were measured. RESULTS: After excluding eight children due to drug refusal or deviation from the protocol, 82 children were included in this study. No differences were found between the groups in terms of median time [interquartile range] to readiness for discharge (midazolam, 90 min [48]; clonidine, 80 min [46]; dexmedetomidine 100.5 min [42]). Compared to the midazolam group, logistic regression with a mixed model and repeated measures approach found no differences in sedation, less emergence delirium, and less pain in the dexmedetomidine group, and less anxiety in both clonidine and dexmedetomidine groups. CONCLUSIONS: No statistical difference was observed in the postoperative recovery times between the premedication regimens. Compared with midazolam, dexmedetomidine was favorable in reducing both emergence delirium and pain in the postoperative care unit, and both clonidine and dexmedetomidine reduced anxiety in the postoperative care unit. Our results indicated that premedication with α2 -agonists had a better recovery profile than short-acting benzodiazepines; although the overall recovery time in the postoperative care unit was not affected.

Cardiorespiratory Response to Sedative Premedication in Preschool Children: A Randomized Controlled Trial Comparing Midazolam, Clonidine, and Dexmedetomidine.

PURPOSE: Sedative premedication in children may negatively impact their cardiorespiratory status during the perioperative course, and no clear consensus exists on the optimal premedication treatment for pediatric patients. The objective was to compare the perioperative cardiorespiratory responses to sedation using three different sedative premedication regimens in preschool children scheduled for surgery with total intravenous anesthesia. DESIGN: A single-center randomized controlled trial. METHODS: This is a planned secondary analysis of a study conducted at a 200-bed tertiary referral hospital. Ninety children participated in the study. They were aged 2-6 years and scheduled for ear, nose, and throat surgery with propofol/remifentanil anesthesia. Participants were randomly assigned to receive oral midazolam 0.5 mg/kg-1 (MID), oral clonidine 4 mcg/kg-1 (CLO), or intranasal dexmedetomidine 2 mcg/kg-1 (DEX). The main outcome measures were the sedation level, based on the Ramsay Sedation Scale (RSS), and cardiorespiratory status, monitored during the perioperative period. FINDINGS: The final cohort had 83 children (MID, n=27; CLO, n=26; DEX, n=30), with similar intergroup patient characteristics. RSS scores were lower in the MID group than in the CLO and DEX groups before induction and within 30 min postsurgery (P<0.001 and P=0.006, respectively). A negative correlation existed between the RSS and heart rate (HR) (r=-0.570, P<0.001). Before anesthesia induction, the respiratory rate was lowest in the DEX group (MID 21.5±1.7 min-1, CLO 20.6±2.6 min-1, DEX 20.2±1.7 min-1; P=0.042). The HR was lower in the CLO and DEX groups than in the MID group (MID, 102.8±10.0 min-1; CLO, 87.4±9.6 min-1; DEX, 87.6±7.9 min-1; P<0.001). The HR was lower immediately after induction (P=0.009) and intraoperatively (P=0.025) in the CLO and DEX groups than in the MID group. CONCLUSIONS: When used as premedication before propofol/remifentanil anesthesia, clonidine and dexmedetomidine provided deeper preoperative sedation compared to midazolam. From a clinical perspective, all three study drugs provided essentially stable cardiovascular and respiratory conditions during the entire perioperative period.

Preoperative anxiety in preschool children: A randomized clinical trial comparing midazolam, clonidine, and dexmedetomidine.

INTRODUCTION: Anxiety in pediatric patients may challenge perioperative anesthesiology management and worsen postoperative outcomes. Sedative drugs aimed to reducing anxiety are available with different pharmacologic profiles, and there is no consensus on their effect or the best option for preschool children. In this study, we aimed to compare the effect of three different premedications on anxiety before anesthesia induction in preschool children aged 2-6 years scheduled for elective surgery. The secondary outcomes comprised distress during peripheral catheter (PVC) insertion, compliance at anesthesia induction, and level of sedation. PATIENTS AND METHODS: In this double-blinded randomized clinical trial, we enrolled 90 participants aged 2-6 years, who were scheduled for elective ear-, nose-and-throat surgery. The participants were randomly assigned to three groups: those who were administered 0.5 mg/kg oral midazolam, 4 µg/kg oral clonidine, or 2 µg/kg intranasal dexmedetomidine. Anxiety, distress during PVC insertion, compliance with mask during preoxygenation, and sedation were measured using the modified Yale Preoperative Anxiety Scale, Behavioral Distress Scale, Induction Compliance Checklist, and Ramsay Sedation Scale, respectively. RESULTS: Six children who refused premedication were excluded, leaving 84 enrolled patients. At baseline, all groups had similar levels of preoperative anxiety and distress. During anesthesia preparation, anxiety was increased in the children who received clonidine and dexmedetomidine; however, it remained unaltered in the midazolam group. There were no differences in distress during PVC insertion or compliance at induction between the groups. The children in the clonidine and dexmedetomidine groups developed higher levels of sedation than those in the midazolam group. CONCLUSIONS: In preschool children, midazolam resulted in a more effective anxiolysis and less sedation compared to clonidine and dexmedetomidine.