Safety and Efficacy Evaluation of S (+) - Ketamine in Children

NCT ID: NCT04834427

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2024-12-04

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.

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; Delirium; Depression, Anxiety; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S (+)-Ketamine group

Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia.

Group Type: EXPERIMENTAL

Conventional therapy + S (+)-Ketamine

Intervention Type: 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:

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.

Control group

Patients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period.

Group Type: ACTIVE_COMPARATOR

Conventional therapy

Intervention Type: 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.

Interventions

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:

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Conventional therapy + S-ketamine; Conventional therapy + Esketamine; Routine treatment

Eligibility Criteria

Inclusion Criteria

1. Age ≤17 years;

2. Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery , ear surgery or other surgeries under general anesthesia;

3. ASA physical status I～Ⅲ;

4. The informed consent form was signed by the patients or the guardians.

Exclusion Criteria

1. The expected length of hospital stay of the patient is less than 48h;

2. Patients expected to be admitted to the ICU after surgery;

3. Patients expected to return to the ward with tracheal catheter after surgery;

4. Be allergic to S (+) - ketamine;

5. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;

6. Patients with congenital heart disease or severely developmental retardation;

7. Patients with any of the following contraindications of S (+) - ketamine:

1. Patients with risk of serious rise of blood pressure or intracranial pressure;

2. Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;

3. Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);

4. Patients with untreated or undertreated hyperthyroidism.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Medical University, China

OTHER

Sponsor Role: collaborator

Beijing Children's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Children's Medical Center

OTHER

Sponsor Role: collaborator

Hunan Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Weidong Mi

Director of the Department of Anesthesiology, Chinese PLA General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weidong Mi, MD

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35870990 (View on PubMed)

Other Identifiers

SAFE-SK-C

Identifier Type: -

Identifier Source: org_study_id