The Comparison of Different Administration Routes of Pediatric Premedication

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Oral administration; 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.; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .; Procedure: Intubation; Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium); All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .
EXPERIMENTAL: 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.	Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .; Procedure: Intubation; Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium); All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .; Other: Intramuscular injection; 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.
EXPERIMENTAL: Rectal perfusion; -At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg	Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .; Procedure: Intubation; Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium); All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .; Other: Rectal perfusion; Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
EXPERIMENTAL: Dripping nose; -At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg	Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .; Procedure: Intubation; Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium); All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .; Other: Dripping nose; Premedicate--At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Publications and helpful links

General Publications

• Haas U, Motsch J, Schreckenberger R, Bardenheuer HJ, Martin E. [Premedication and preoperative fasting in pediatric anesthesia. Results of a survey]. Anaesthesist. 1998 Oct;47(10):838-43. doi: 10.1007/s001010050633. German.
• Kain ZN, Mayes LC, Bell C, Weisman S, Hofstadter MB, Rimar S. Premedication in the United States: a status report. Anesth Analg. 1997 Feb;84(2):427-32. doi: 10.1097/00000539-199702000-00035.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: November 27, 2014
• First Submitted That Met QC Criteria: December 7, 2014
• First Posted (ESTIMATE): December 10, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 7, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Sedation; Preanesthetic medication; Administration route
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Anesthetics; Fentanyl; Midazolam; Propofol; Atracurium
• Other Study ID Numbers: administration route