The Comparison of Different Administration Routes of Pediatric Premedication

NCT02313337 | Unknown Phase 4

• 1 other identifier: administration route
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anesthesia

Keywords

Administration route; Preanesthetic medication; Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• Postoperation recovery assess (Wake up agitation score (PAED)、Steward score 、Postoperative recovery score)

  10 min after extubation

• Postoperative behavior assessment (Postoperative behavior scale (PHBQ)

  1 day after the operation，7 day after the operation

Study Arms (4)

Oral administration

EXPERIMENTAL

-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; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); Procedure: Intubation; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Intramuscular injection

EXPERIMENTAL

-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; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); Procedure: Intubation; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Rectal perfusion

EXPERIMENTAL

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

Other: Rectal perfusion; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); Procedure: Intubation; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Dripping nose

EXPERIMENTAL

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

Other: Dripping nose; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); Procedure: Intubation; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Interventions

Oral administration 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.

Oral administration

Intramuscular injection 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.

Intramuscular injection

Rectal perfusion OTHER

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

Rectal perfusion

Dripping nose OTHER

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

Dripping nose

Anesthesia induction(midazolam,fentanyl,propofol,atracurium) 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 .

Dripping nose; Intramuscular injection; Oral administration; Rectal perfusion

Intubation PROCEDURE

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

Dripping nose; Intramuscular injection; Oral administration; Rectal perfusion

Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium) DRUG

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

Dripping nose; Intramuscular injection; Oral administration; Rectal perfusion

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Related 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. doi: 10.1007/s001010050633. German.

  PMID: 9830555 BACKGROUND

• 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.

  PMID: 9024042 BACKGROUND

MeSH Terms

Interventions

Administration, Oral; Injections, Intramuscular; Intubation

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Injections; Investigative Techniques

Study Officials

• NIU XIAOLI

  The second affiliated hospital of xi 'an jiaotong university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 10, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 10, 2014

Record last verified: 2014-11