Different Premedication in Pediatric Patients

Effects of Different Premedication on Preoperative Sedation and Postoperative Agitation in Children Undergoing Ophthalmic and Otorhinolaryngologic Operations

The investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group.

Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthe-sia Emergence Delirium [PAED] scale) and POV were assessed in the postanesthetic care unit (PACU).Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU and patients' satisfaction degree were also assessed.

Study Overview

• Status: Completed
• Conditions: Agitation
• Intervention / Treatment: Drug: Saline; Drug: midazolam; Drug: midazolam; Drug: dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-

Exclusion Criteria:

• a recent history of upper respiratory tract infection, a known allergy to dexmedetomidine or midazolam, inability to understand the consent process or parental refusal.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo; no premedication	Drug: Saline; no premedication
EXPERIMENTAL: oralmidazolam; 0.5 mg/kg oral midazolam group	Drug: midazolam; 0.5mg/kg oral midazolam; Drug: midazolam; 0.05mg/kg intravenous injection midazolam
EXPERIMENTAL: intravenous midazolam; 0.05 mg/kg intravenous injection midazolam group	Drug: midazolam; 0.5mg/kg oral midazolam; Drug: midazolam; 0.05mg/kg intravenous injection midazolam
EXPERIMENTAL: dexmedetomidine; 2.5µg/kg intranasal dexmedetomidine group	Drug: dexmedetomidine; 2.5µg/kg intranasal dexmedetomidine group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation	Rarely awake, needs shaking or shouting to wake up; Asleep, eyes closed, wakes up when called softly or lightly touched; Sleepy but eyes open spontaneously; Awake; Agitated	10 minutes after premedication
Sedation	Rarely awake, needs shaking or shouting to wake up; Asleep, eyes closed, wakes up when called softly or lightly touched; Sleepy but eyes open spontaneously; Awake; Agitated	20 minutes after premedication
Sedation	Rarely awake, needs shaking or shouting to wake up; Asleep, eyes closed, wakes up when called softly or lightly touched; Sleepy but eyes open spontaneously; Awake; Agitated	30 minutes after premedication
Emotional state	Calm; Apprehensive, not smiling, tentative behaviour, withdrawn; Crying; Thrashing, crying with movement of arms and legs, resisting	0 minutes after they were separated from their parents
Emotional state	Calm; Apprehensive, not smiling, tentative behaviour, withdrawn; Crying; Thrashing, crying with movement of arms and legs, resisting	0 minutes after intravenous cannulation
Emotional state	Calm; Apprehensive, not smiling, tentative behaviour, withdrawn; Crying; Thrashing, crying with movement of arms and legs, resisting	0 minutes after facemask application

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 13, 2020
• Primary Completion (ACTUAL): November 15, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (ACTUAL): February 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; 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: 20180341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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