Different Premedication in Pediatric Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Agitation

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: midazolam
* Drug: midazolam
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>no premedication | Drug: Saline<br>* no premedication<br>|
| Experimental: oralmidazolam<br>0.5 mg/kg oral midazolam group | Drug: midazolam<br>* 0.5mg/kg oral midazolam<br>|
| Experimental: intravenous midazolam<br>0.05 mg/kg intravenous injection midazolam group | Drug: midazolam<br>* 0.05mg/kg intravenous injection midazolam<br>|
| Experimental: dexmedetomidine<br>2.5µg/kg intranasal dexmedetomidine group | Drug: dexmedetomidine<br>* 2.5µg/kg intranasal dexmedetomidine group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Emotional state | Calm Apprehensive, not smiling, tentative behaviour, withdrawn Crying Thrashing, crying with movement of arms and legs, resisting | 0 minutes after intravenous cannulation | 
| Emotional state | Calm Apprehensive, not smiling, tentative behaviour, withdrawn Crying Thrashing, crying with movement of arms and legs, resisting | 0 minutes after facemask application |