The Comparison of Different Administration Routes of Pediatric Premedication

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02313337
• Other study ID #: administration route
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 27, 2014
• Last updated: December 7, 2014
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.
• 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.
• Rectal perfusion
Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
• Dripping nose
Premedicate--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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

References & Publications (2)

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. German. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Postoperative behavior assessment (Postoperative behavior scale (PHBQ)	Postoperative behavior scale (PHBQ)	1 day after the operation,7 day after the operation	No