S-ketamin Premedication in Pediatric EENT Surgery

Ketamine

Brief Summary

We aim to investigate the effects of premedication (intranasal or intravenous administration) of s-ketamin, dexmedetomidine, and combination for premedication in children undergoing ENT surgery.

Intervention / Treatment

  • S-ketamine 0.3 (DRUG)
    0.3 μg/kg intravenous injection s-ketamin
  • S-Ketamine 0.5 (DRUG)
    0.5 μg/kg intravenous injection s-ketamin
  • S-ketamine 2 (DRUG)
    2 μg/kg intranasal s-ketamin
  • S-ketamine 1+Dexmedetomidine 1 (DRUG)
    1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
  • S-ketamine 0.5 +Dexmedetomidine 2 (DRUG)
    0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine

Condition or Disease

  • Emotions
  • Separation Anxiety
  • Pain, Procedural

Phase

  • Early Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 2 Years to 12 Years
    Enrollment: 320 (ACTUAL)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Mar 01, 2021 ACTUAL
    Primary Completion: Sep 01, 2021 ACTUAL
    Completion Date: Jan 01, 2022 ACTUAL
    Study First Posted: Feb 17, 2021 ACTUAL
    Last Updated: Apr 20, 2022

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A

    Three hundred children aged between 2 and 12 years were randomly allocated to one of five groups: 0.3 μg/kg intravenous injection s-ketamin; 0.5 μg/kg intravenous injection s-ketamin; 2 μg/kg intranasal s-ketamin group; 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine group; 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine group.

    The modified Yale Preoperative Anxiety Scale (m-YPAS) was used to assess preoperative anxiety at 1, 5, 10, 20, and 30min after premedication. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthesia Emergence Delirium \[PAED\] scale) and POV was assessed in the postanesthetic care unit (PACU). Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU, and patients' satisfaction degree were also assessed.

    Participant Groups

    • 0.3 μg/kg intravenous injection s-ketamin

    • 0.5 μg/kg intravenous injection s-ketamin

    • 2 μg/kg intranasal s-ketamin

    • 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine

    • 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine

    Eligibility Criteria

    Sex: All
    Minimum Age: 2
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * After obtaining the informed consent from their parents or proxies, the children aged 2 to 12 years, scheduled for elective ENT surgery, of American Society of Anesthesiologists (ASA) I or II were enrolled in this study.

    Exclusion Criteria:

    * Congenital heart diseases, congenital dysplasia, obstructive sleep apnea syndrome, upper respiratory tract infection, body mass index (BMI) ≥25, allergy to S-ketamin or dexmedetomidine, and severe liver or kidney disease.

    Primary Outcomes

    • A validated observational tool for assessing children's anxiety

    • A validated observational tool for assessing children's anxiety

    • A validated observational tool for assessing children's anxiety

    • A validated observational tool for assessing children's anxiety

    • A validated observational tool for assessing children's anxiety

    Secondary Outcomes

    • 1. = easy separation 2. = whimpers, but is easily reassured, not clinging 3. = cries and cannot be easily reassured, but not clinging to parents 4. = crying and clinging to parents

    • Successful venous cannulation was defined as an ESS-4 ≤2 at the time of attempted cannulation, regardless of whether the vein was actually cannulated on the first attempt.

    More Details

    NCT Number: NCT04757675
    Other IDs: Premedication s-ketamin
    Study URL: https://clinicaltrials.gov/study/NCT04757675
    Last updated: Sep 29, 2023