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

Primary Purpose

S-ketamine, Esketamine, Acute Pain

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Conventional therapy + S (+)-Ketamine
Conventional therapy
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for S-ketamine

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≤17 years;
  2. Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery or ear surgery 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.

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S (+)-Ketamine group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
Opioid consumption
Total opioid consumption(conversion to equivalent morphine)

Secondary Outcome Measures

Full Information

First Posted
April 2, 2021
Last Updated
April 3, 2021
Sponsor
Chinese PLA General Hospital
Collaborators
Southern Medical University, China, Beijing Children's Hospital, Shanghai Children's Medical Center, Hunan Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04834427
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Southern Medical University, China, Beijing Children's Hospital, Shanghai Children's Medical Center, Hunan Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
S-ketamine, Esketamine, Acute Pain, Postoperative Pain, Analgesia, Hyperalgesia, Delirium, Depression, Anxiety, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Experimental group : Control group=2:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S (+)-Ketamine group
Arm Type
Experimental
Arm Description
Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period.
Intervention Type
Drug
Intervention Name(s)
Conventional therapy + S (+)-Ketamine
Other Intervention Name(s)
Conventional therapy + S-ketamine, Conventional therapy + Esketamine
Intervention Description
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: 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. Intramuscular injection：The dose is 2~4 mg/kg.
Intervention Type
Drug
Intervention Name(s)
Conventional therapy
Other Intervention Name(s)
Routine treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
The area under the broken line of FLACC scale score
Description
Only for children aged 0~7 years. The score of FLACC Scale is 0-10, the higher the score, the more severe the pain.
Time Frame
Hour 0-48 after surgery
Title
The area under the broken line of Numerical Rating Scale score
Description
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.
Time Frame
Hour 0-48 after surgery
Title
Opioid consumption
Description
Total opioid consumption(conversion to equivalent morphine)
Time Frame
Hour 0-48 after surgery
Other Pre-specified Outcome Measures:
Title
FLACC scale score
Description
Only for children aged 0~7 years. The score of FLACC Scale is 0-10, the higher the score, the more severe the pain. 8≤Age ≤17 years: NRS pain score at 2h, 4h, 24h, 48h after surgery.
Time Frame
Hour 0-48 after surgery
Title
Numerical Rating Scale score
Description
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.
Time Frame
Hour 0-48 after surgery
Title
Time of first rescue analgesia
Description
The time from the end of the operation to the first rescue analgesics after the operation. Rescue analgesia refers to the analgesia according to the patient's or guardian's requirements in addition to routine postoperative analgesia.
Time Frame
Hour 0-48 after surgery
Title
The incidence of rescue analgesia
Description
Rescue analgesia refers to the analgesia according to the patient's or guardian's requirements in addition to routine postoperative analgesia.
Time Frame
Hour 0-48 after surgery
Title
Recovery time
Description
The time from the end of the operation to recovery(can be awakened)
Time Frame
Day 0
Title
The incidence of emergence delirium
Description
Only for children aged 0-7 years. Evaluating by the Pediatric Emergence Delirium Rating Scale(PAED) ,the score of the scale is 0~20, when the total score is greater than 10, it is considered that the child has delirium.The scale will be evaluated 10minutes, 20minutes, 30minutes after extubation.
Time Frame
Day 0
Title
The incidence of unexpected intraoperative events
Description
Unexpected events during operation include intraoperative cough, laryngeal spasm, body movement, tachycardia, decreased oxygen saturation, respiratory depression, bradycardia, hypertension and hypotension.
Time Frame
Intraoperative
Title
The incidence of adverse events after surgery
Description
The incidence of adverse events from the end of the operation to 48h after surgery. Including nausea, vomiting, increased secretions, dizziness, oversedation, infection,anesthetic awareness, nightmares, restlessness, pruritus, disorientation, delirium, respiratory depression, diplopia, diarrhea, intestinal obstruction, urinary retention, gastroesophageal reflux, constipation, chills, hallucinations, etc.
Time Frame
Hour 0-48 after surgery
Title
Children's Depression Inventory(CDI) score
Description
Only for children aged 8~17.Children's Depression Inventory(CDI) scale include 27 questions ,from 0 to 54pionts, the higher the score, the more severe the depressive symptoms.
Time Frame
Hour 48 after surgery
Title
Hospital Anxiety and Depression Scale(HAD）score
Description
Only for children aged 14~17.Hospital Anxiety and Depression Scale(HAD）include anxiety measure(7 questions,0-21pionts) and depression measure(7 questions,0-21pionts),the higher the score, the more severe the symptoms.
Time Frame
Hour 48 after surgery
Title
Pharmacoeconomic indicators
Description
Calculating incremental cost-effectiveness ratio （ICER）based on cost-effectiveness analysis.
Time Frame
Hour 48 after surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≤17 years; Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery or ear surgery under general anesthesia; ASA physical status I～Ⅲ; The informed consent form was signed by the patients or the guardians. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Mi, MD
Phone
8613381082966
Email
wwdd1962@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Wang, MD
Phone
8613661363231
Email
301wh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weidong Mi, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Mi, MD
Phone
8613381082966
Email
wwdd1962@aliyun.com
First Name & Middle Initial & Last Name & Degree
Hong Wang, MD
Phone
8613661363231
Email
301wh@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35870990
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.
Results Reference
derived

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

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