Comparison of Dexmedetomidine and Midazolam for Prevention of Emergence Delirium in Children
Condition: Tonsillitis
MeSH terms: Tonsillitis; Delirium; Emergence Delirium
Study type: Interventional

Summary: 
      Emergence delirium is a common complication in children after anesthesia. The incidence of
      emergence delirium is reported upto 50%. Prevention of emergence delirium in children is
      important not only for the patient safety but also for the satisfaction of the parents.
      Midazolam is the most commonly used medications for prevention of emergence delirium.
      However, it might lead to delayed awakening from anesthesia and respiratory depression. In
      this study, the investigators will evaluate whether dexmedetomidine can be effectively and
      safely administered for prevention of emergence delirium in children compared to midazolam.
    

Detailed description: 
      In this study, seventy patients scheduled for elective tonsillectomy aged from 24 months to
      12 years old Anesthesiologists physical status (ASA) class 1 and 2 will be enrolled. The
      sample size was calculated based on the former study with a type 1 error estimate of 0.05 at
      80% power. The proportion in dexmedetomidine group (group D) was assumed to be 0.4 and the
      proportion in midazolam group (group M) was 0.1. Considering the drop-out rate of 10%,
      seventy patients in total were needed.The patients will randomly be allocated into the group
      D or the group M. The group D will receive dexmedetomidine0.3mcg/kg mixed with 0.9% normal
      saline, 10mL in total. The group M will receive 0.03mg/kg of midazolam mixed with 0.9% normal
      saline, 10mL in total. Randomization and drug administration will be done by a single
      anesthesiologist. Assessment of the patient will be done by another anesthesiologist blinded
      by the group. Five minutes before the end of the surgery, the study drug will be slowly
      infused for 5 minutes. In the postanesthesia circuit unit (PACU), presence of emergence
      delirium will be assessed. The emergence delirium will be assessed by the four-point
      agitation scale. (1 = calm, 2 = not calm but gould be easily calmed, 3 = not easily calmed,
      moderately agitated or restless, and 4 = combative, exited or disoriented.) Patients with
      score 3 and 4 will be diagnosed as emergence delirium and treated with intravenous fentanyl
      1mcg/kg. Severity of emergence delirium will be assessed with the pediatric anesthesia
      emergence delirium scale after 10 mins on arrival of PACU. Pain wil be scored by 5-point
      scale (0 = no pain, 5 = severe pain ever). Time from discontinuation of anesthetic gas to
      extubate will be recorded. The data will be compared between the groups by the independent
      t-test or Mann-Whitney test for the continuous variables. Chi-square test or Fisher's exact
      test will be used for the categorial variables.
    

Intervention name(s): Dexmedetomidine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous dexmedetomidine 0.3mcg/kg is slowly infused at 5 minutes before the end of surgery; Intravenous dexmedetomidine 0.03mg/kg is slowly infused at 5 minutes before the end of surgery
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention