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

Phase 4

• Conditions: Delirium; S-ketamine; Esketamine; Postoperative Pain; Analgesia; Hyperalgesia; Children; Acute Pain; Depression, Anxiety
• Interventions: Drug: Conventional therapy + S (+)-Ketamine; Drug: Conventional therapy

• Registration Number: NCT04834427
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-03
• Study First Posted: 2021-04-08
• Study Start: 2022-04-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S (+)-Ketamine group	Conventional therapy + S (+)-Ketamine	Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia.
Control group	Conventional therapy	Patients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period.

Primary Outcome Measures

Name	Time	Method
The area under the broken line of FLACC scale score	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	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	Hour 0-48 after surgery	Total opioid consumption(conversion to equivalent morphine)

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China