The Comparison of Different Administration Routes of Pediatric Premedication

Study Overview
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Brief Summary
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The study purpose is to compare the effect of different Administration Routes of Pediatric Premedication (including oral administration, intramuscular injection, rectal perfusion, intranasal).

Detailed Description
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In this study, 80 cases of surgical or otolaryngology children undergoing elective surgery were divided into four groups：oral administration group, intramuscular group, rectal infusion group, intranasal group depending on the route of administration before anesthesia. By observing the difference of sedative effects, postoperative recovery, and postoperative psychological behavior among the four groups,compare the effect of four pre-anesthetic administration routes.

Official Title
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The Comparison of Different Administration Routes of Pediatric Premedication-Single Center,Randomized，Controlled Trial

Conditions
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Anesthesia

Intervention / Treatment
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* Other: Oral administration
* Other: Intramuscular injection
* Other: Rectal perfusion
* Other: Dripping nose
* Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)
* Procedure: Intubation
* Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent of children's parents; Children patient in pediatric surgery and E.N.T. department; surgery time 1   3 hours; Aged between 1 and 7 years old; American Society of Anesthesiologists (ASA)classification:class I II; Exclusion Criteria: With cardiovascular and respiratory complications; A history of the endocrine system; A long history of application of sedative drugs; Water and electrolyte balance disorder preoperatively; Liver and kidney dysfunction; Nervous system dysfunction; High gastrointestinal obstruction; Tracheoesophageal fistula, trachea foreign body, hiatal hernia, dysphagia; Lung infection, atelectasis; Congenital heart disease(CHD); Severe malnutrition; Traumatic or ischemia anoxic encephalopathy, high cranial pressure; Anesthesia and surgery was conducted in 3 days;

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral administration<br>-Oral administration of a mixture at preoperative 30 minutes : ketamine 3 mg/kg, midazolam 0.5 mg/kg and atropine 0.02 mg/kg, plus 50% glucose solution to 0.5ml /kg. | Other: Oral administration<br>* Premedicate--Oral administration of a mixture at preoperative 30 minutes: ketamine 3 mg/kg, midazolam 0.5 mg/kg and atropine 0.02 mg/kg, plus 50% glucose solution to 0.5ml /kg.<br>Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)<br>* After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .<br>Procedure: Intubation<br>* Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.<br>Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)<br>* All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .<br>|
| Experimental: Intramuscular injection<br>-At preoperative 30 minutes intramuscular injection of atropine 0.02 mg/kg, 5 minutes before entering the operation room, intramuscular injection of ketamine 5 mg/kg. | Other: Intramuscular injection<br>* Premedicate--At preoperative 30 minutes intramuscular injection of atropine 0.02 mg/kg, 5 minutes before entering the operation room, intramuscular injection of ketamine 5 mg/kg.<br>Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)<br>* After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .<br>Procedure: Intubation<br>* Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.<br>Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)<br>* All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .<br>|
| Experimental: Rectal perfusion<br>-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg | Other: Rectal perfusion<br>* Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg<br>Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)<br>* After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .<br>Procedure: Intubation<br>* Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.<br>Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)<br>* All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .<br>|
| Experimental: Dripping nose<br>-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg | Other: Dripping nose<br>* Premedicate--At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg<br>Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)<br>* After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .<br>Procedure: Intubation<br>* Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.<br>Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)<br>* All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation Score |  | Try to break away from family membersan，an expected average of 3 min；Successfully break away from the family members and accept the face mask and venipuncture，an expected average of 5 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic and anesthetic depth monitoring (Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS) | Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS) | From premedication to 10 min after extubation up to 4 hours | 
| Stress index monitoring (The concentration of Plasma cortisol and blood sugar) | The concentration of Plasma cortisol and blood sugar | From anesthesia induction to 10 min after the start of surgery up to 30 min | 
| Postoperation recovery assess (Wake up agitation score (PAED)、Steward score 、Postoperative recovery score) | Wake up agitation score (PAED)、Steward score 、Postoperative recovery score | 10 min after extubation | 
| Postoperative behavior assessment (Postoperative behavior scale (PHBQ) | Postoperative behavior scale (PHBQ) | 1 day after the operation，7 day after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Administration route, Preanesthetic medication, Sedation