The Comparison of Different Administration Routes of Pediatric Premedication

NCT ID: NCT02313337

Last Updated: 2014-12-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Anesthesia

Keywords

Administration route; Preanesthetic medication; Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral administration

Intervention Type: OTHER

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.

Anesthesia induction(midazolam,fentanyl,propofol,atracurium)

Intervention Type: DRUG

After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .

Intubation

Intervention Type: PROCEDURE

Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.

Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Intervention Type: DRUG

All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .

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.

Group Type: EXPERIMENTAL

Intramuscular injection

Intervention Type: OTHER

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.

Anesthesia induction(midazolam,fentanyl,propofol,atracurium)

Intervention Type: DRUG

After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .

Intubation

Intervention Type: PROCEDURE

Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.

Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Intervention Type: DRUG

All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .

Rectal perfusion

-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg

Group Type: EXPERIMENTAL

Rectal perfusion

Intervention Type: OTHER

Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg

Anesthesia induction(midazolam,fentanyl,propofol,atracurium)

Intervention Type: DRUG

After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .

Intubation

Intervention Type: PROCEDURE

Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.

Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Intervention Type: DRUG

All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .

Dripping nose

-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg

Group Type: EXPERIMENTAL

Dripping nose

Intervention Type: OTHER

Premedicate--At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg

Anesthesia induction(midazolam,fentanyl,propofol,atracurium)

Intervention Type: DRUG

After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .

Intubation

Intervention Type: PROCEDURE

Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.

Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Intervention Type: DRUG

All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Rectal perfusion

Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg

Intervention Type: OTHER

Dripping nose

Premedicate--At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg

Intervention Type: OTHER

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 .

Intervention Type: DRUG

Intubation

Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.

Intervention Type: PROCEDURE

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 .

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

NIU XIAOLI

Role: PRINCIPAL_INVESTIGATOR

The second affiliated hospital of xi 'an jiaotong university

References

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.

Reference Type: BACKGROUND

PMID: 9830555 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9024042 (View on PubMed)

Other Identifiers

administration route

Identifier Type: -

Identifier Source: org_study_id