Comparison of Dexmedetomidine and Midazolam for Prevention of Emergence Delirium in Children

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.

Study Overview

• Status: Completed
• Conditions: Tonsillitis
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing elective tonsillectomy under general anesthesia
• American society of anesthesiologist physical status 1,2
• aged from 24 months to 12 years old
• obtaining written informed consent

Exclusion Criteria:

• known history of allergy to dexmedetomidine or midazolam
• renal impairment
• hepatic impairment
• long QT syndrome
• developmental disorder
• congenital disorder
• neurologic disorder
• psychogenic disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dexmedetomidine group; Subjects who receive dexmedetomidine for prevention of emergence delirium	Drug: Dexmedetomidine; Intravenous dexmedetomidine 0.3mcg/kg is slowly infused at 5 minutes before the end of surgery
ACTIVE_COMPARATOR: Midazolam group; Subjects who receive midazolam for prevention of emergence delirium	Drug: Midazolam; Intravenous dexmedetomidine 0.03mg/kg is slowly infused at 5 minutes before the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Emergence Delirium (ED)	During the PACU stay, the patients will be assessed whether the emergence delirium (ED) occurred. It is defined as ED, if the highest score is more than 3 points after five time point measurements by the four-point agitation scale (1=calm, 2=not calm but easily calmed, 3=not easily calmed, moderately agitated, and 4=combative, excited, disoriented). The five time points are the 0 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes after arrival at the PACU.	0 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes after arrival at the PACU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Emergence Delirium	Patients will be scored using the pediatric anesthesia emergence delirium scale. This consists of 5 criteria, each of which is pointed from 0 to 5 according to the severity. Total score stands for the delirium severity.	10 minutes after arrival at the PACU
Emergence time	Time from the discontinuation of the anesthetic gas to extubation.	3 minutes after extubation

Collaborators and Investigators

• Sponsor: Eunah Cho, MD

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2017
• Primary Completion (ACTUAL): December 17, 2018
• Study Completion (ACTUAL): December 17, 2018

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (ACTUAL): November 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 6, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Delirium; Emergence Delirium; Tonsillitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: 2017-04-038-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No