Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children

Ketamine

Brief Summary

The investigators intend to study the safety and effectiveness of opioid free anesthesia compared to opioid anesthesia in ambulatory surgery in children, regarding postoperative pain, hemodynamic stability, agitation and discharge times. Quality of postanesthetic care was estimated in a 24h follow up.

Intervention / Treatment

  • Ketamine, dexmedetomidine (DRUG)
    Patients will receive non-opioid analgesics, such as dexmedetomidine, ketamine perioperatively
  • fentanyl, remifentanil (DRUG)
    Patients will receive opioid analgesics, such as fentanyl and remifentanil perioperatively

Condition or Disease

  • Effect of Anesthesia in Postoperative Pain
  • Effect of Anesthesia in Extubation Time
  • Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit
  • Effect of Anesthesia in Postoperative Adverse Events
  • Effect of Anesthesia in Discharge Time From the Hospital

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Years to 16 Years
    Enrollment: 100 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2018 ACTUAL
    Primary Completion: Aug 01, 2019 ACTUAL
    Completion Date: Aug 01, 2019 ACTUAL
    Study First Posted: Jun 07, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 11, 2020

    Sponsors / Collaborators

    Lead Sponsor: Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
    Responsible Party: N/A

    Location

    Athens, Greece

    Participant Groups

    • In group A opioid free anesthesia is administered. Anesthesia and analgesia were achieved with ketamine(1mg/kg, bolus), dexmedetomidine(1mcg/kg, over 10 minutes), local anesthetic(ropivacaine 2mg/kg 0.75% wound infiltration), paracetamol(15mg/kg), non steroid analgesics(diclofenac 1mg/kg). Anesthesia induction with ketamine(1mg/kg), propofol 1% 2-3mg/kg, rocuronium 1mg/kg. Anesthesia maintenance with propofol 1% 10mg/kg/hour. Reversal of rocuronium with sugammadex 2mg/kg.

    • In group B opioid based anesthesia is administered.Anesthesia and analgesia were achieved with remifentanil(0.3mcg/kg/minute), local anesthetic(ropivacaine 2mg/kg 0.75% wound infiltration), paracetamol(15mg/kg), non steroid analgesics(diclofenac 1mg/kg).Anesthesia induction with propofol 1% 2-3mg/kg,fentanyl(2mcg/kg), rocuronium 1mg/kg. Anesthesia maintenance with propofol 1% 10mg/kg/hour. Reversal of rocuronium with sugammadex 2mg/kg.

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 16
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * children,
    * American Society Anesthesia I, II,
    * ambulatory surgery

    Exclusion Criteria:

    * Allergy to anesthetic and analgesic drugs,
    * history of neuromuscular,
    * renal, neurological, hepatic disease,
    * craniofacial anomalies,
    * Obstructive Sleep Apnea,
    * obesity,
    * cardiopulmonary diseases

    Primary Outcomes

    • Comparison of the discharge times from the hospital between opioid free and opioid based anesthesia using Discharge criteria based on physiological scoring system, evaluating respiration, circulation, level of consciousness, postoperative pain, postoperative nausea and vomiting and surgical site. A score 12 or more allows patient to leave safely from the hospital.

    • Comparison of the severity of postoperative pain between opioid free and opioid based anesthesia using Visual Analogue Scale for children aged 7 years and more. We instruct the patient to point to the position on the line between the faces to indicate how much pain they are currently feeling. The far left end indicates "no pain"(0) and the far right end indicates "worst pain ever."(10)

    • Comparison of the severity of postoperative pain between opioid free and opioid based anesthesia using the Face, Legs, Activity, Cry, Consolability scale or FLACC scale for children between the ages of 3 years and 7 years. The scale has five criteria, which are each assigned a score of 0, 1 or 2.The scale is scored in a range of 0-10 with 0 representing no pain.

    Secondary Outcomes

    • Comparison of extubation time, time interval between discontinuation of anesthetics and extubation between the two groups

    • Comparison of discharge time from postanesthesia unit, time interval between arrival from operating room until leaving postanesthesia unit, between the two groups using Aldrete scale, score of 9 or greater allows patient to leave postanesthesia unit

    • Comparison of hospitalization fees among the two groups

    More Details

    NCT Number: NCT03979469
    Other IDs: Opioid free anesthesia 7.2018
    Study URL: https://clinicaltrials.gov/study/NCT03979469
    Last updated: Sep 29, 2023