Safety and Efficacy Evaluation of S (+) - Ketamine in Children
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: S (+)-Ketamine group Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia. |
Drug: Conventional therapy + S (+)-Ketamine
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:
Intravenous injection：Bolus intravenous injection before skin incision, the dose is 0.1~0.25 mg/kg; Bolus intravenous injection (dose 0.1~0.25 mg/kg) before skin incision + continuous intravenous infusion (dose of 0.1~0.25 mg/kg/h) during operation; Continuous intravenous infusion after surgery with a dose of 0.02~0.1 mg/kg/h for 24~48 h.
Intramuscular injection：The dose is 2~4 mg/kg.
Other Names:
|
| Active Comparator: Control group Patients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period. |
Drug: Conventional therapy
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The area under the broken line of FLACC scale score [Hour 0-48 after surgery]
Only for children aged 0~7 years. The score of FLACC Scale is 0-10, the higher the score, the more severe the pain.
- The area under the broken line of Numerical Rating Scale score [Hour 0-48 after surgery]
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.
- Opioid consumption [Hour 0-48 after surgery]
Total opioid consumption(conversion to equivalent morphine)
Other Outcome Measures
- FLACC scale score [Hour 0-48 after surgery]
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.
- Numerical Rating Scale score [Hour 0-48 after surgery]
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.
- Time of first rescue analgesia [Hour 0-48 after surgery]
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.
- The incidence of rescue analgesia [Hour 0-48 after surgery]
Rescue analgesia refers to the analgesia according to the patient's or guardian's requirements in addition to routine postoperative analgesia.
- Recovery time [Day 0]
The time from the end of the operation to recovery(can be awakened)
- The incidence of emergence delirium [Day 0]
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.
- The incidence of unexpected intraoperative events [Intraoperative]
Unexpected events during operation include intraoperative cough, laryngeal spasm, body movement, tachycardia, decreased oxygen saturation, respiratory depression, bradycardia, hypertension and hypotension.
- The incidence of adverse events after surgery [Hour 0-48 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.
- Children's Depression Inventory(CDI) score [Hour 48 after surgery]
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.
- Hospital Anxiety and Depression Scale(HAD）score [Hour 48 after surgery]
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.
- Pharmacoeconomic indicators [Hour 48 after surgery]
Calculating incremental cost-effectiveness ratio （ICER）based on cost-effectiveness analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≤17 years;
-
Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery or ear surgery under general anesthesia;
-
ASA physical status I～Ⅲ;
-
The informed consent form was signed by the patients or the guardians.
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:
-
Patients with risk of serious rise of blood pressure or intracranial pressure;
-
Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;
-
Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);
-
Patients with untreated or undertreated hyperthyroidism.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese PLA General Hospital | Beijing | Beijing | China |
Sponsors and Collaborators
- Chinese PLA General Hospital
- Southern Medical University, China
- Beijing Children's Hospital
- Shanghai Children's Medical Center
- Hunan Children's Hospital
Investigators
- Study Chair: Weidong Mi, MD, Chinese PLA General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAFE-SK-C