A Phase 4 interventional study of Conventional therapy + S (+)-Ketamine and Conventional therapy in S-ketamine, Esketamine and Acute Pain, sponsored by Chinese PLA General Hospital. Enrolling by invitation at 1 site in China. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Chinese PLA General Hospital · Phase 4, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with any of the following of S (+) - ketamine:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia.
Drug: Conventional therapy + S (+)-Ketamine
Patients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period.
Drug: Conventional therapy
Drug page: Esketamine
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: 1. 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. 2. Intramuscular injection：The dose is 2\~4 mg/kg.
Also known as: Conventional therapy + S-ketamine, Conventional therapy + Esketamine
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.
Also known as: Routine treatment
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.
Time frame: 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.
Time frame: Hour 0-48 after surgery
Opioid consumption
Total opioid consumption(conversion to equivalent morphine)
Time frame: Hour 0-48 after surgery
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.
Time frame: Hour 0-48 after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: Hour 0-48 after surgery
Recovery time
The time from the end of the operation to recovery(can be awakened)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Hour 48 after surgery
Pharmacoeconomic indicators
Calculating incremental cost-effectiveness ratio （ICER）based on cost-effectiveness analysis.
Time frame: Hour 48 after surgery
Plan to share: No
Started Apr 2022 (actual). Primary completion is estimated for Dec 2024, 31 months after the start.
Of 79 non-industry phase 4 interventional studies under Acute Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 32. This study's planned 31 months is above that.
Counting every sponsor, half of 84 studies reached it within 19 months; a quarter within 9 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Esketamine
Chinese PLA General Hospital →