Different Premedication in Pediatric Patients

Not Applicable

Completed

• Conditions: Agitation
• Interventions: Drug: Saline; Drug: midazolam; Drug: dexmedetomidine

• Registration Number: NCT04266340
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-12
• Study Start: 2020-12-13
• Primary Completion: 2021-11-15
• Study Completion: 2021-12-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Saline	no premedication
oralmidazolam	midazolam	0.5 mg/kg oral midazolam group
intravenous midazolam	midazolam	0.05 mg/kg intravenous injection midazolam group
dexmedetomidine	dexmedetomidine	2.5µg/kg intranasal dexmedetomidine group

Primary Outcome Measures

Name	Time	Method
Sedation	30 minutes after premedication	1. Rarely awake, needs shaking or shouting to wake up; 2. Asleep, eyes closed, wakes up when called softly or lightly touched; 3. Sleepy but eyes open spontaneously; 4. Awake; 5. Agitated
Emotional state	0 minutes after facemask application	1. Calm; 2. Apprehensive, not smiling, tentative behaviour, withdrawn; 3. Crying; 4. Thrashing, crying with movement of arms and legs, resisting

Trial Locations

Locations (1)

Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China