A Comparison of the Sedation During Endoscopy in Children

Brief Summary

The primary aim of this study was to investigate the efficiency and safety of midazolam plus ketamine versus fentanyl plus propofol administered to children undergoing UGE and to determine the most appropriate sedation protocol.

Intervention / Treatment

  • Ketamine and Midazolam (DRUG)
    This group was injected intravenous midazolam 0.1 mg/kg (maximum 4 mg), two minutes later, ketamine 1 mg/kg was given intravenously before the start of endoscopy.
  • Propofol and Fentanyl (DRUG)
    This group was injected intravenous fentanyl 1 mcg/kg, and two minutes later, propofol 1 mg/kg was given intravenously before the start of endoscopy.

Condition or Disease

  • Failed Moderate Sedation During Procedure

Phase

  • Phase 4
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 4 Years to 17 Years
    Enrollment: 238 (ACTUAL)
    Funded by: Other
    Allocation: Randomized

    Masking

    SINGLE:
    • Investigator

    Clinical Trial Dates

    Start date: Jan 01, 2015
    Primary Completion: Jul 01, 2015 ACTUAL
    Completion Date: Sep 01, 2015 ACTUAL
    Study First Posted: Apr 08, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 08, 2016

    Sponsors / Collaborators

    Responsible Party: N/A

    The patients were given a spray of lidocaine 10% as a topical pharyngeal anaesthesia before sedation. Intravenous midazolam bolus dose 0.1 mg/kg (maximum 4 mg) was administered to Group A. Two minutes later, ketamine bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after ketamine application. Ketamine 0.5 mg/kg (maximum of 2 mg/kg) was added in two minute intervals if adequate sedation was not achieved initially. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a ketamine 0.5 mg/kg single dose was applied. Intravenous fentanyl bolus dose 1µg/kg was administered to Group B. Two minutes later, propofol bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after propofol application. Propofol 0.5 mg/kg was added in two minute intervals if adequate sedation was not achieved. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a propofol 0.5 mg/kg single dose was applied. None of the patients were given an antidote after the process during recovery.

    All patients were monitored for peripheral oxygen saturation, heart rate (HR), respiratory rate, and RSS during the procedure. Oxygen (2L/min) by nasal cannula was given to all patients during the procedure. Hypoxia (peripheral oxygen saturation \<90% during 60 seconds), apnea, laryngospasm, tachycardia (defined as 30% more than the average heart rate by age), bradycardia (30% less than the average heart rate by age), increase in oral secretions (more than enough to warrant aspiration), flushing, coughing and vomiting were assessed as complications and recorded.

    Participant Groups

    • ketamine 1 mg/kg midazolam 0.1 mg/kg

    • propofol 1 mg/kg fentanyl 1 mcg/kg

    Eligibility Criteria

    Sex: All
    Minimum Age: 4
    Maximum Age: 17
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * All the patients were in ASA (American Society of Anesthesiologists) physical status I or II.

    Exclusion Criteria:

    * Patients with respiratory tract infections, glaucoma, psychosis, porphyria, hypertension, metabolic or neurologic diseases, increased intracranial pressure and intracranial mass, and patients known to be allergic to the drugs used were excluded from the study.

    Primary Outcomes
    • the effectiviness of midazolam plus ketamine versus fentanyl plus propofol according to a modified Ramsay sedation score

    Secondary Outcomes
    • number of patients with adverse events that are related to study drugs

    • procedure time is defined as the time between the insertion of endoscope and removal of endoscope

    • recovery time is defined as the time from completing the endoscopy to achieving Aldrete score 10 in the recovery unit Aldrete score

    More Details

    NCT Number: NCT02732132
    Other IDs: 2015/18
    Study URL: https://clinicaltrials.gov/study/NCT02732132
    Last updated: Sep 29, 2023