Different Premedication in Pediatric Patients

Eye & ENT Hospital of Fudan University

Status: Completed

Conditions: Agitation

Treatments: Drug: dexmedetomidine; Drug: midazolam; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04266340

20180341

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 4 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

no premedication

Treatment:

Drug: Saline

oralmidazolam

Experimental group

Description:

0.5 mg/kg oral midazolam group

Treatment:

Drug: midazolam

Drug: midazolam

intravenous midazolam

Experimental group

Description:

0.05 mg/kg intravenous injection midazolam group

Treatment:

Drug: midazolam

Drug: midazolam

dexmedetomidine

Experimental group

Description:

2.5µg/kg intranasal dexmedetomidine group

Treatment:

Drug: dexmedetomidine