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Completed

NCT Number: NCT04266340

Different Premedication in Pediatric Patients

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.

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Key information

Conditions

Agitation Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

2.5µg/kg intranasal dexmedetomidine group

midazolam

Drug

0.5mg/kg oral midazolam

Saline

Drug

no premedication

Primary outcomes

  1. Sedation

    Time frame: 10 minutes after premedication

    • 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

  2. Sedation

    Time frame: 20 minutes after premedication

    • 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

  3. Sedation

    Time frame: 30 minutes after premedication

    • 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

  4. Emotional state

    Time frame: 0 minutes after they were separated from their parents

    • Calm
    • Apprehensive, not smiling, tentative behaviour, withdrawn
    • Crying
    • Thrashing, crying with movement of arms and legs, resisting

  5. Emotional state

    Time frame: 0 minutes after intravenous cannulation

    • Calm
    • Apprehensive, not smiling, tentative behaviour, withdrawn
    • Crying
    • Thrashing, crying with movement of arms and legs, resisting

  6. Emotional state

    Time frame: 0 minutes after facemask application

    • Calm
    • Apprehensive, not smiling, tentative behaviour, withdrawn
    • Crying
    • Thrashing, crying with movement of arms and legs, resisting

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2020
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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