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

NCT04834427 | Enrolling By Invitation Phase 4

• 1 other identifier: SAFE-SK-C
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  Hour 0-48 after surgery

• Opioid consumption

  Total opioid consumption(conversion to equivalent morphine)

  Hour 0-48 after surgery

Other Outcomes (11)

• FLACC scale score

  Hour 0-48 after surgery

• Numerical Rating Scale score

  Hour 0-48 after surgery

• Time of first rescue analgesia

  Hour 0-48 after surgery

Study Arms (2)

S (+)-Ketamine group

EXPERIMENTAL

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

Drug: Conventional therapy + S (+)-Ketamine

Control group

ACTIVE COMPARATOR

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

Drug: Conventional therapy

Interventions

Conventional therapy + S (+)-Ketamine 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.

Also known as: Conventional therapy + S-ketamine, Conventional therapy + Esketamine

S (+)-Ketamine group

Conventional therapy 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.

Also known as: Routine treatment

Control group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Southern Medical University, China: collaborator
• Beijing Children's Hospital: collaborator
• Shanghai Children's Medical Center: collaborator
• Hunan Children's Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 35870990 DERIVED

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Agnosia; Hyperalgesia; Delirium; Depression; Anxiety Disorders

Interventions

Ketamine; Esketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Somatosensory Disorders; Sensation Disorders; Confusion; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Weidong Mi, MD

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Anesthesiology, Chinese PLA General Hospital

Model Details: Experimental group : Control group=2:1

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 8, 2021
• Study Start: April 20, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 4, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)