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| Name | Class |
|---|---|
| Southern Medical University, China | OTHER |
| Beijing Children's Hospital | OTHER |
| Shanghai Children's Medical Center | OTHER |
| Hunan Children's Hospital |
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A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in children in perioperative settings.
Children often suffer acute pain,awakening delirium, anxiety and depression after operation which may affect the recovery of children. S (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese children undergoing surgery.
Objective:
To evaluate the analgesic effect of perioperative administration of S (+) - ketamine on postoperative acute pain in children undergoing surgery, and explore the effects of S (+) - ketamine on postoperative awakening delirium, postoperative anxiety and depression mood ,as well find the best usage, including dose, timing, compatibility, and type of operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S (+)-Ketamine group | Experimental | Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia. |
|
| Control group | Active Comparator | Patients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional therapy + S (+)-Ketamine | Drug | In principle, there are no specific restrictions on the dosage, mode of administration, timing, and compatibility of S-ketamine hydrochloride injection, but the recommended dosage is given, which is lower than the dosage specified in the instructions. Recommended use and dosage of S (+)-Ketamine:
|
| Measure | Description | Time Frame |
|---|---|---|
| The area under the broken line of FLACC scale score | Only for children aged 0~7 years. The score of FLACC Scale is 0-10, the higher the score, the more severe the pain. | Hour 0-48 after surgery |
| The area under the broken line of Numerical Rating Scale score | Only for children aged 8~17years. The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain. | Hour 0-48 after surgery |
| Opioid consumption | Total opioid consumption(conversion to equivalent morphine) | Hour 0-48 after surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| FLACC scale score | Only for children aged 0~7 years. The score of FLACC Scale is 0-10, the higher the score, the more severe the pain. 8≤Age ≤17 years: NRS pain score at 2h, 4h, 24h, 48h after surgery. | Hour 0-48 after surgery |
| Numerical Rating Scale score |
Inclusion Criteria:
Exclusion Criteria:
The expected length of hospital stay of the patient is less than 48h;
Patients expected to be admitted to the ICU after surgery;
Patients expected to return to the ward with tracheal catheter after surgery;
Be allergic to S (+) - ketamine;
Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
Patients with congenital heart disease or severely developmental retardation;
Patients with any of the following contraindications of S (+) - ketamine:
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| Name | Affiliation | Role |
|---|---|---|
| Weidong Mi, MD | Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35870990 | Derived | Wang H, Duan C, Zhang J, Qu S, Sun Y, Zhou L, Yang L, Lan C, Mi W, Chen P. Evaluation of the effect of perioperative administration of S(+)-ketamine hydrochloride injection for postoperative acute pain in children: study protocol for a prospective, multicenter, randomized, open-label, parallel-group, pragmatic clinical trial. Trials. 2022 Jul 23;23(1):586. doi: 10.1186/s13063-022-06534-z. |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| D006930 | Hyperalgesia |
| D003693 | Delirium |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| C000629870 | Esketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| OTHER_GOV |
Experimental group : Control group=2:1
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|
|
| Conventional therapy | Drug | Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine. |
|
|
Only for children aged 8~17years. The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain.
| Hour 0-48 after surgery |
| Time of first rescue analgesia | The time from the end of the operation to the first rescue analgesics after the operation. Rescue analgesia refers to the analgesia according to the patient's or guardian's requirements in addition to routine postoperative analgesia. | Hour 0-48 after surgery |
| The incidence of rescue analgesia | Rescue analgesia refers to the analgesia according to the patient's or guardian's requirements in addition to routine postoperative analgesia. | Hour 0-48 after surgery |
| Recovery time | The time from the end of the operation to recovery(can be awakened) | Day 0 |
| The incidence of emergence delirium | Only for children aged 0-7 years. Evaluating by the Pediatric Emergence Delirium Rating Scale(PAED) ,the score of the scale is 0~20, when the total score is greater than 10, it is considered that the child has delirium.The scale will be evaluated 10minutes, 20minutes, 30minutes after extubation. | Day 0 |
| The incidence of unexpected intraoperative events | Unexpected events during operation include intraoperative cough, laryngeal spasm, body movement, tachycardia, decreased oxygen saturation, respiratory depression, bradycardia, hypertension and hypotension. | Intraoperative |
| The incidence of adverse events after surgery | The incidence of adverse events from the end of the operation to 48h after surgery. Including nausea, vomiting, increased secretions, dizziness, oversedation, infection,anesthetic awareness, nightmares, restlessness, pruritus, disorientation, delirium, respiratory depression, diplopia, diarrhea, intestinal obstruction, urinary retention, gastroesophageal reflux, constipation, chills, hallucinations, etc. | Hour 0-48 after surgery |
| Children's Depression Inventory(CDI) score | Only for children aged 8~17.Children's Depression Inventory(CDI) scale include 27 questions ,from 0 to 54pionts, the higher the score, the more severe the depressive symptoms. | Hour 48 after surgery |
| Hospital Anxiety and Depression Scale(HAD）score | Only for children aged 14~17.Hospital Anxiety and Depression Scale(HAD）include anxiety measure(7 questions,0-21pionts) and depression measure(7 questions,0-21pionts),the higher the score, the more severe the symptoms. | Hour 48 after surgery |
| Pharmacoeconomic indicators | Calculating incremental cost-effectiveness ratio （ICER）based on cost-effectiveness analysis. | Hour 48 after surgery |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D003221 | Confusion |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |