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The Comparison of Different Administration Routes of Pediatric Premedication

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ClinicalTrials.gov Identifier: NCT02313337
Recruitment Status : Unknown
Verified November 2014 by Second Affiliated Hospital of Xi'an Jiaotong University.
Recruitment status was:  Not yet recruiting
First Posted : December 10, 2014
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Xi'an Jiaotong University

Tracking Information
First Submitted Date  ICMJE November 27, 2014
First Posted Date  ICMJE December 10, 2014
Last Update Posted Date December 10, 2014
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2014)
Sedation Score [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2014)
  • Hemodynamic and anesthetic depth monitoring (Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS) [ Time Frame: From premedication to 10 min after extubation up to 4 hours ]
    Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS)
  • Stress index monitoring (The concentration of Plasma cortisol and blood sugar) [ Time Frame: From anesthesia induction to 10 min after the start of surgery up to 30 min ]
    The concentration of Plasma cortisol and blood sugar
  • Postoperation recovery assess (Wake up agitation score (PAED)、Steward score 、Postoperative recovery score) [ Time Frame: 10 min after extubation ]
    Wake up agitation score (PAED)、Steward score 、Postoperative recovery score
  • Postoperative behavior assessment (Postoperative behavior scale (PHBQ) [ Time Frame: 1 day after the operation,7 day after the operation ]
    Postoperative behavior scale (PHBQ)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Comparison of Different Administration Routes of Pediatric Premedication
Official Title  ICMJE The Comparison of Different Administration Routes of Pediatric Premedication-Single Center,Randomized,Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • 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.
  • 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.
  • Other: Rectal perfusion
    Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
  • Other: 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 .
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Oral administration
    • Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)
    • Procedure: Intubation
    • Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,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.
    Interventions:
    • Other: Intramuscular injection
    • Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)
    • Procedure: Intubation
    • Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)
  • Experimental: Rectal perfusion
    -At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
    Interventions:
    • Other: Rectal perfusion
    • Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)
    • Procedure: Intubation
    • Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)
  • Experimental: Dripping nose
    -At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
    Interventions:
    • Other: Dripping nose
    • Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)
    • Procedure: Intubation
    • Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 7, 2014)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02313337
Other Study ID Numbers  ICMJE administration route
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Second Affiliated Hospital of Xi'an Jiaotong University
Study Sponsor  ICMJE Second Affiliated Hospital of Xi'an Jiaotong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: NIU XIAOLI The second affiliated hospital of xi 'an jiaotong university
PRS Account Second Affiliated Hospital of Xi'an Jiaotong University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP