S-ketaminePhase 4NCT04834427
Safety and Efficacy Evaluation of S (+) - Ketamine in Children
A Phase 4 study testing Conventional therapy + S (+)-Ketamine and Conventional therapy in people with S-ketamine and Esketamine, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- S-ketamine, Esketamine, Acute Pain
- What is being tested?
- Conventional therapy + S (+)-Ketamine and Conventional therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2022to 4 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≤17 years;
- Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery , ear surgery or other surgeries under general anesthesia;
- ASA physical status I～Ⅲ;
- The informed consent form was signed by the patients or the guardians.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy Evaluation of S (+) -Ketamine for Postoperative Acute Pain in Children in Perioperative Settings: A Multicenter, Randomized, Open-label, Active Controlled Pragmatic Clinical Trial
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.
Read the 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.
- Conditions
- S-ketamine, Esketamine, Acute Pain, Postoperative Pain, Analgesia, Hyperalgesia
- Being tested
- Conventional therapy + S (+)-Ketamine, Conventional therapy
- Medical subject headings
- Acute Pain, Pain, Postoperative, Agnosia, Hyperalgesia, Delirium, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapy + S (+)-KetamineDrug
Also called Conventional therapy + S-ketamine, Conventional therapy + 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:
- 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.
Also called Routine treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| S (+)-Ketamine group | Experimental | Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia. Receives: Drug: Conventional therapy + S (+)-Ketamine |
| Control group | Active comparator | Patients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period. Receives: Drug: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Hour 0-48 after surgery
Opioid consumption
Total opioid consumption(conversion to equivalent morphine)
Measured: Hour 0-48 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start20 Apr 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion4 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for S-ketamineStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group : Control group=2:1
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Medical University, China, Beijing Children's Hospital, Shanghai Children's Medical Center, Hunan Children's Hospital
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Weidong Mi, MD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834427
- Sponsor's protocol ID
- SAFE-SK-C
- Status last verified
- Mar 2024
- First submitted
- 2 Apr 2021
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35870990
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of S (+) -Ketamine for Postoperative Acute Pain in Children in Perioperative Settings: A Multicenter, Randomized, Open-label, Active Controlled Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT04834427
- Acronym / sponsor ID
- SAFE-SK-C
- Conditions
- S-ketamine, Esketamine, Acute Pain, Postoperative Pain, Analgesia, Hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Southern Medical University, China, Beijing Children's Hospital, Shanghai Children's Medical Center, Hunan Children's Hospital
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 4 Dec 2024 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group : Control group=2:1
| Arm | Type | Receives |
|---|---|---|
| S (+)-Ketamine group | Experimental | Drug: Conventional therapy + S (+)-KetaminePatients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia. |
| Control group | Active comparator | Drug: Conventional therapyPatients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age ≤17 years;
- Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery , ear surgery or other surgeries under general anesthesia;
- ASA physical status I～Ⅲ;
- The informed consent form was signed by the patients or the guardians.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional therapy + S (+)-KetamineAlso: Conventional therapy + S-ketamine, Conventional therapy + EsketamineIn 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. | Drug | S (+)-Ketamine group |
| Conventional therapyAlso: Routine treatmentReceiving 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. | Drug | Control group |
Primary outcome
The area under the broken line of FLACC scale score
Time frame: 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
Time frame: 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
Time frame: Hour 0-48 after surgery
Total opioid consumption(conversion to equivalent morphine)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Derived from this study: PubMed 35870990Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weidong Mi, MD study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional therapy + S (+)-Ketamine and Conventional therapy in people with S-ketamine and Esketamine, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the broken line of FLACC scale score (time frame: Hour 0-48 after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.