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Different Premedication in Pediatric Patients

Primary Purpose

Agitation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dexmedetomidine
midazolam
midazolam
Saline
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

placebo

oralmidazolam

intravenous midazolam

dexmedetomidine

Arm Description

no premedication

0.5 mg/kg oral midazolam group

0.05 mg/kg intravenous injection midazolam group

2.5µg/kg intranasal dexmedetomidine group

Outcomes

Primary Outcome Measures

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Calm Apprehensive, not smiling, tentative behaviour, withdrawn Crying Thrashing, crying with movement of arms and legs, resisting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Calm Apprehensive, not smiling, tentative behaviour, withdrawn Crying Thrashing, crying with movement of arms and legs, resisting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Calm Apprehensive, not smiling, tentative behaviour, withdrawn Crying Thrashing, crying with movement of arms and legs, resisting

Secondary Outcome Measures

Full Information

First Posted
January 13, 2020
Last Updated
May 5, 2022
Sponsor
Eye & ENT Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04266340
Brief Title
Different Premedication in Pediatric Patients
Official Title
Effects of Different Premedication on Preoperative Sedation and Postoperative Agitation in Children Undergoing Ophthalmic and Otorhinolaryngologic Operations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2020 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
no premedication
Arm Title
oralmidazolam
Arm Type
Experimental
Arm Description
0.5 mg/kg oral midazolam group
Arm Title
intravenous midazolam
Arm Type
Experimental
Arm Description
0.05 mg/kg intravenous injection midazolam group
Arm Title
dexmedetomidine
Arm Type
Experimental
Arm Description
2.5µg/kg intranasal dexmedetomidine group
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
2.5µg/kg intranasal dexmedetomidine group
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
0.5mg/kg oral midazolam
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
0.05mg/kg intravenous injection midazolam
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
no premedication
Primary Outcome Measure Information:
Title
Sedation
Description
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
Time Frame
10 minutes after premedication
Title
Sedation
Description
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
Time Frame
20 minutes after premedication
Title
Sedation
Description
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
Time Frame
30 minutes after premedication
Title
Emotional state
Description
Calm Apprehensive, not smiling, tentative behaviour, withdrawn Crying Thrashing, crying with movement of arms and legs, resisting
Time Frame
0 minutes after they were separated from their parents
Title
Emotional state
Description
Calm Apprehensive, not smiling, tentative behaviour, withdrawn Crying Thrashing, crying with movement of arms and legs, resisting
Time Frame
0 minutes after intravenous cannulation
Title
Emotional state
Description
Calm Apprehensive, not smiling, tentative behaviour, withdrawn Crying Thrashing, crying with movement of arms and legs, resisting
Time Frame
0 minutes after facemask application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Different Premedication in Pediatric Patients

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