The Comparison of Different Administration Routes of Pediatric Premedication

Ketamine

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).

Intervention / Treatment

  • 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.
  • 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.
  • Rectal perfusion (OTHER)
    Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
  • Dripping nose (OTHER)
    Premedicate--At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
  • 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 .
  • Intubation (PROCEDURE)
    Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.
  • 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 .

Condition or Disease

  • Anesthesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 1 Year to 7 Years
    Enrollment: 80 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Dec 01, 2014
    Primary Completion: Dec 01, 2015 ESTIMATED
    Completion Date: Dec 01, 2015 ESTIMATED
    Study First Posted: Dec 10, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Dec 07, 2014

    Sponsors / Collaborators

    Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

    • -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.

    • -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.

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 7
    Age Groups: Child
    Healthy Volunteers: Yes

    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;

    Primary Outcomes
    • 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

    • Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS)

    • The concentration of Plasma cortisol and blood sugar

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

    • Postoperative behavior scale (PHBQ)

    More Details

    NCT Number: NCT02313337
    Other IDs: administration route
    Study URL: https://clinicaltrials.gov/study/NCT02313337
    Last updated: Sep 29, 2023