Skip to main content
OpenTrials
Completed

NCT Number: NCT03979469

Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Childrens Hospital P. and A. Kyriakou Anesthesiology Department

Athens, 11526, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Discharge times from the hospital

    Time frame: 4 hours

    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.

  2. Severity of postoperative pain

    Time frame: 24 hours

    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)

  3. Severity of postoperative pain

    Time frame: 24 hours

    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

  1. Extubation time

    Time frame: 30 minutes

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

  2. Discharge time from PACU

    Time frame: 60 minutes

    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

  3. Cost effect

    Time frame: 24 hours

    Comparison of hospitalization fees among the two groups

Sponsors and collaborators

Lead sponsor

Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

Other

Registry information

Official study title

Criteria Based Discharge in Ambulatory Surgery in Children Undergoing Opioid Versus Opioid Free Anesthesia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2019
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.