A Phase 2 interventional study of Ketamine, dexmedetomidine and fentanyl, remifentanil in Effect of Anesthesia in Postoperative Pain, Effect of Anesthesia in Extubation Time and Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit, sponsored by Athens General Children's Hospital "Pan. & Aglaia Kyriakou". Completed at 1 site in Greece. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by Athens General Children's Hospital "Pan. & Aglaia Kyriakou" · Phase 2, Interventional, and Other
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 100 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Athens General Children's Hospital "Pan. & Aglaia Kyriakou" is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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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
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
Drug pages: Ketamine · Dexmedetomidine
Patients will receive non-opioid analgesics, such as dexmedetomidine, ketamine perioperatively
Drug pages: Fentanyl · Remifentanil
Patients will receive opioid analgesics, such as fentanyl and remifentanil perioperatively
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.
Time frame: 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)
Time frame: 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.
Time frame: 24 hours
Extubation time
Comparison of extubation time, time interval between discontinuation of anesthetics and extubation between the two groups
Time frame: 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
Time frame: 60 minutes
Cost effect
Comparison of hospitalization fees among the two groups
Time frame: 24 hours
Plan to share: No
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ketamine · Dexmedetomidine
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"