The Comparison of Different Administration Routes of Pediatric Premedication

Phase 4

• Conditions: Anesthesia
• Interventions: Other: Oral administration; Other: Dripping nose; Other: Intramuscular injection; Other: Rectal perfusion; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); Procedure: Intubation; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

• Registration Number: NCT02313337
• Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2014-11
• Study First Submitted: 2014-11-27
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-07
• Last Update Submitted: 2014-12-07
• Study First Posted: 2014-12-10
• Last Update Posted: 2014-12-10
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral administration	Oral administration	-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.
Oral administration	Intubation	-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.
Oral administration	Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)	-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.
Rectal perfusion	Intubation	-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
Oral administration	Anesthesia induction(midazolam,fentanyl,propofol,atracurium)	-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.
Intramuscular injection	Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)	-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.
Rectal perfusion	Anesthesia induction(midazolam,fentanyl,propofol,atracurium)	-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
Rectal perfusion	Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)	-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
Dripping nose	Dripping nose	-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
Dripping nose	Anesthesia induction(midazolam,fentanyl,propofol,atracurium)	-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
Dripping nose	Intubation	-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
Intramuscular injection	Intramuscular injection	-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.
Rectal perfusion	Rectal perfusion	-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
Dripping nose	Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)	-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
Intramuscular injection	Anesthesia induction(midazolam,fentanyl,propofol,atracurium)	-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.
Intramuscular injection	Intubation	-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.

Primary Outcome Measures

Name	Time	Method
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

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