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Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children

Primary Purpose

Effect of Anesthesia in Postoperative Pain, Effect of Anesthesia in Extubation Time, Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Ketamine, dexmedetomidine
fentanyl, remifentanil
Sponsored by
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Effect of Anesthesia in Postoperative Pain

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Childrens Hospital P. and A. Kyriakou Anesthesiology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

opiod free general anesthesia

opioid based general anesthesia

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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)
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.

Secondary Outcome Measures

Extubation time
Comparison of extubation time, time interval between discontinuation of anesthetics and extubation between the two groups
Discharge time from PACU
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
Cost effect
Comparison of hospitalization fees among the two groups

Full Information

First Posted
May 9, 2019
Last Updated
July 11, 2020
Sponsor
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
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1. Study Identification

Unique Protocol Identification Number
NCT03979469
Brief Title
Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children
Official Title
Criteria Based Discharge in Ambulatory Surgery in Children Undergoing Opioid Versus Opioid Free Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
opiod free general anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
opioid based general anesthesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine, dexmedetomidine
Intervention Description
Patients will receive non-opioid analgesics, such as dexmedetomidine, ketamine perioperatively
Intervention Type
Drug
Intervention Name(s)
fentanyl, remifentanil
Intervention Description
Patients will receive opioid analgesics, such as fentanyl and remifentanil perioperatively
Primary Outcome Measure Information:
Title
Discharge times from the hospital
Description
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.
Time Frame
4 hours
Title
Severity of postoperative pain
Description
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)
Time Frame
24 hours
Title
Severity of postoperative pain
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Extubation time
Description
Comparison of extubation time, time interval between discontinuation of anesthetics and extubation between the two groups
Time Frame
30 minutes
Title
Discharge time from PACU
Description
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
Time Frame
60 minutes
Title
Cost effect
Description
Comparison of hospitalization fees among the two groups
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Childrens Hospital P. and A. Kyriakou Anesthesiology Department
City
Athens
ZIP/Postal Code
11526
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children

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