Different Premedication in Pediatric Patients

Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266340
• Other study ID #: 20180341
• Status: Completed
• Phase: N/A
• Start date: December 13, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2022
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 1, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agitation
• Psychomotor Agitation

Intervention

Drug:
• dexmedetomidine
2.5µg/kg intranasal dexmedetomidine group
• midazolam
0.5mg/kg oral midazolam
• midazolam
0.05mg/kg intravenous injection midazolam
• Saline
no premedication

Locations

Country	Name	City	State
China	Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Emotional state	Calm; Apprehensive, not smiling, tentative behaviour, withdrawn; Crying; Thrashing, crying with movement of arms and legs, resisting	0 minutes after intravenous cannulation
Primary	Emotional state	Calm; Apprehensive, not smiling, tentative behaviour, withdrawn; Crying; Thrashing, crying with movement of arms and legs, resisting	0 minutes after facemask application