Effect of Anesthesia in Postoperative PainPhase 2NCT03979469
Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children
A Phase 2 study testing Ketamine, dexmedetomidine and fentanyl, remifentanil in people with Effect of Anesthesia in Postoperative Pain and Effect of Anesthesia in Extubation Time, run by Athens General Children's Hospital "Pan. & Aglaia Kyriakou" at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Effect of Anesthesia in Postoperative Pain, Effect of Anesthesia in Extubation Time, Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit
- What is being tested?
- Ketamine, dexmedetomidine and fentanyl, remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Aug 2018to 1 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children,
- American Society Anesthesia I, II,
- ambulatory surgery
Who cannot join
- Allergy to anesthetic and analgesic drugs,
- history of neuromuscular,
- renal, neurological, hepatic disease,
- craniofacial anomalies,
- Obstructive Sleep Apnea,
- obesity,
- cardiopulmonary diseases
Trial locations and contacts
1 site in 1 country.
Greece1 site
Childrens Hospital P. and A. Kyriakou Anesthesiology Department
Athens, 11526
About this study
Official title: Criteria Based Discharge in Ambulatory Surgery in Children Undergoing Opioid Versus Opioid Free Anesthesia
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
- Being tested
- Ketamine, dexmedetomidine, fentanyl, remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine, dexmedetomidineDrug
Patients will receive non-opioid analgesics, such as dexmedetomidine, ketamine perioperatively
fentanyl, remifentanilDrug
Patients will receive opioid analgesics, such as fentanyl and remifentanil perioperatively
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: fentanyl, remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 24 hours
Secondary outcomes (3)
Extubation time
Comparison of extubation time, time interval between discontinuation of anesthetics and extubation between the two groups
Measured: 30 minutes
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
Measured: 60 minutes
Cost effect
Comparison of hospitalization fees among the two groups
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Aug 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Anesthesia in Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adelais Tsiotou, Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979469
- Sponsor's protocol ID
- Opioid free anesthesia 7.2018
- Status last verified
- Jul 2020
- First submitted
- 9 May 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Criteria Based Discharge in Ambulatory Surgery in Children Undergoing Opioid Versus Opioid Free Anesthesia
- ClinicalTrials.gov ID
- NCT03979469
- Acronym / sponsor ID
- Opioid free anesthesia 7.2018
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou"University, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opiod free general anesthesia | Experimental | Drug: Ketamine, dexmedetomidineIn 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. |
| opioid based general anesthesia | Active comparator | Drug: fentanyl, remifentanilIn 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. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children,
- American Society Anesthesia I, II,
- ambulatory surgery
Key exclusion criteria (7 listed)
- Allergy to anesthetic and analgesic drugs,
- history of neuromuscular,
- renal, neurological, hepatic disease,
- craniofacial anomalies,
- Obstructive Sleep Apnea,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine, dexmedetomidinePatients will receive non-opioid analgesics, such as dexmedetomidine, ketamine perioperatively | Drug | opiod free general anesthesia |
| fentanyl, remifentanilPatients will receive opioid analgesics, such as fentanyl and remifentanil perioperatively | Drug | opioid based general anesthesia |
Primary outcome
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.
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)
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.
3 secondary outcomes
Extubation time
Time frame: 30 minutes
Discharge time from PACU
Time frame: 60 minutes
Cost effect
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine, dexmedetomidine and fentanyl, remifentanil in people with Effect of Anesthesia in Postoperative Pain and Effect of Anesthesia in Extubation Time, run by Athens General Children's Hospital "Pan. & Aglaia Kyriakou" at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge times from the hospital (time frame: 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.