Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

Ketamine

Brief Summary

comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy.

Intervention / Treatment

  • Fentanyl (DRUG)
    fentanyl used with propofol for sedation
  • Ketamine (DRUG)
    ketamine used with propofol for sedation

Condition or Disease

  • Sedation

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 6 Years to 16 Years
    Enrollment: 60 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Double blind

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Aug 16, 2017 ESTIMATED
    Primary Completion: Jun 15, 2018 ESTIMATED
    Completion Date: Aug 15, 2018 ESTIMATED
    Study First Posted: Aug 01, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 01, 2017

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    It is a prospective double blinded controlled study that will be carried out on 60 pediatric patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:- Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.

    Participant Groups

    • Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.

    • Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.

    Eligibility Criteria

    Sex: All
    Minimum Age: 6
    Maximum Age: 16
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Pediatric patients undergoing diagnostic GIT endoscopy
    * ASA I-II

    Exclusion Criteria:

    * Emergency endoscopy
    * Respiratory infection and hyperactive airways
    * History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs
    * Morbid obesity, and neuropsychiatric disorders

    Primary Outcomes

    • when oxygen saturation below 90%

    More Details

    NCT Number: NCT03235609
    Other IDs: 17100212
    Study URL: https://clinicaltrials.gov/study/NCT03235609
    Last updated: Sep 29, 2023