Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children

NCT03979469 | Completed Phase 2

• 1 other identifier: Opioid free anesthesia 7.2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Discharge times from the hospital

  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.

  4 hours

• Severity of postoperative pain

  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)

  24 hours

• Severity of postoperative pain

  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.

  24 hours

Secondary Outcomes (3)

• Extubation time

  30 minutes

• Discharge time from PACU

  60 minutes

• Cost effect

  24 hours

Study Arms (2)

opiod free general anesthesia

EXPERIMENTAL

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.

Drug: Ketamine, dexmedetomidine

opioid based general anesthesia

ACTIVE COMPARATOR

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.

Drug: fentanyl, remifentanil

Interventions

Ketamine, dexmedetomidine DRUG

Patients will receive non-opioid analgesics, such as dexmedetomidine, ketamine perioperatively

opiod free general anesthesia

fentanyl, remifentanil DRUG

Patients will receive opioid analgesics, such as fentanyl and remifentanil perioperatively

opioid based general anesthesia

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Childrens Hospital P. and A. Kyriakou Anesthesiology Department

Athens, 11526, Greece

Location

MeSH Terms

Interventions

Ketamine; Dexmedetomidine; Fentanyl; Remifentanil

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Propionates; Acids, Acyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Anesthesiology Department

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: June 7, 2019
• Study Start: August 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)