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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Invitation-only; Phase 4

Conditions: Postoperative Pain; Delirium; Esketamine; Hyperalgesia; S-ketamine; Depression, Anxiety; Children; Analgesia; Acute Pain

Treatments: Drug: Conventional therapy; Drug: Conventional therapy + S (+)-Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04834427

SAFE-SK-C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

S (+)-Ketamine group

Experimental group

Description:

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

Treatment:

Drug: Conventional therapy + S (+)-Ketamine

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Conventional therapy