Clinical trial NCT04834427: Safety and Efficacy Evaluation of S (+) - Ketamine in Children
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: S-ketamine
Esketamine
Acute Pain
Postoperative Pain
Analgesia
Hyperalgesia
Delirium
Depression, Anxiety
Children
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
name: Beijing Children's Hospital
name: Shanghai Children's Medical Center
name: Hunan Children's Hospital
First posted: 2021-04-08
Enrollment: 3000
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group : Control group=2:1
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The area under the broken line of FLACC scale score
timeFrame: Hour 0-48 after surgery
measure: The area under the broken line of Numerical Rating Scale score
timeFrame: Hour 0-48 after surgery
measure: Opioid consumption
timeFrame: Hour 0-48 after surgery
Secondary outcomes:
Other outcomes:
measure: FLACC scale score
timeFrame: Hour 0-48 after surgery
measure: Numerical Rating Scale score
timeFrame: Hour 0-48 after surgery
measure: Time of first rescue analgesia
timeFrame: Hour 0-48 after surgery
measure: The incidence of rescue analgesia
timeFrame: Hour 0-48 after surgery
measure: Recovery time
timeFrame: Day 0
measure: The incidence of emergence delirium
timeFrame: Day 0
measure: The incidence of unexpected intraoperative events
timeFrame: Intraoperative
measure: The incidence of adverse events after surgery
timeFrame: Hour 0-48 after surgery
measure: Children's Depression Inventory(CDI) score
timeFrame: Hour 48 after surgery
measure: Hospital Anxiety and Depression Scale(HAD）score
timeFrame: Hour 48 after surgery
measure: Pharmacoeconomic indicators
timeFrame: Hour 48 after surgery
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Weidong Mi, MD
role: STUDY_CHAIR
References:
citation: 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.