Agitation
Conditions
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.
Interventions
DRUGdexmedetomidine
2.5µg/kg intranasal dexmedetomidine group
DRUGmidazolam
0.5mg/kg oral midazolam
DRUGSaline
no premedication
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedation | 10 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 they were separated from their parents | 1. Calm 2. Apprehensive, not smiling, tentative behaviour, withdrawn 3. Crying 4. Thrashing, crying with movement of arms and legs, resisting |
Countries
China
Outcome results
None listed