Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit Clinical Trial
Official title:
Criteria Based Discharge in Ambulatory Surgery in Children Undergoing Opioid Versus Opioid Free Anesthesia
| Verified date | July 2020 |
| Source | Athens General Children's Hospital "Pan. & Aglaia Kyriakou" |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | August 1, 2019 |
| Est. primary completion date | August 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 16 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Greece | Childrens Hospital P. and A. Kyriakou Anesthesiology Department | Athens |
| Lead Sponsor | Collaborator |
|---|---|
| Athens General Children's Hospital "Pan. & Aglaia Kyriakou" |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Extubation time | Comparison of extubation time, time interval between discontinuation of anesthetics and extubation between the two groups | 30 minutes | |
| Secondary | 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 | 60 minutes | |
| Secondary | Cost effect | Comparison of hospitalization fees among the two groups | 24 hours |