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

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ClinicalTrials.gov Identifier: NCT04834427
Recruitment Status : Not yet recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Southern Medical University, China
Beijing Children's Hospital
Shanghai Children's Medical Center
Hunan Children's Hospital
Information provided by (Responsible Party):
Weidong Mi, Chinese PLA General Hospital

Tracking Information
First Submitted Date  ICMJE April 2, 2021
First Posted Date  ICMJE April 8, 2021
Last Update Posted Date April 8, 2021
Estimated Study Start Date  ICMJE May 1, 2021
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2021)
  • The area under the broken line of FLACC scale score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Hour 0-48 after surgery ]
    Total opioid consumption(conversion to equivalent morphine)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 3, 2021)
  • FLACC scale score [ Time Frame: 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. 8≤Age ≤17 years: NRS pain score at 2h, 4h, 24h, 48h after surgery.
  • Numerical Rating Scale score [ Time Frame: 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.
  • Time of first rescue analgesia [ Time Frame: Hour 0-48 after surgery ]
    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.
  • The incidence of rescue analgesia [ Time Frame: Hour 0-48 after surgery ]
    Rescue analgesia refers to the analgesia according to the patient's or guardian's requirements in addition to routine postoperative analgesia.
  • Recovery time [ Time Frame: Day 0 ]
    The time from the end of the operation to recovery(can be awakened)
  • The incidence of emergence delirium [ Time Frame: Day 0 ]
    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.
  • The incidence of unexpected intraoperative events [ Time Frame: Intraoperative ]
    Unexpected events during operation include intraoperative cough, laryngeal spasm, body movement, tachycardia, decreased oxygen saturation, respiratory depression, bradycardia, hypertension and hypotension.
  • The incidence of adverse events after surgery [ Time Frame: Hour 0-48 after surgery ]
    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.
  • Children's Depression Inventory(CDI) score [ Time Frame: Hour 48 after surgery ]
    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.
  • Hospital Anxiety and Depression Scale(HAD)score [ Time Frame: Hour 48 after surgery ]
    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.
  • Pharmacoeconomic indicators [ Time Frame: Hour 48 after surgery ]
    Calculating incremental cost-effectiveness ratio (ICER)based on cost-effectiveness analysis.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Evaluation of S (+) - Ketamine in Children
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Experimental group : Control group=2:1
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • S-ketamine
  • Esketamine
  • Acute Pain
  • Postoperative Pain
  • Analgesia
  • Hyperalgesia
  • Delirium
  • Depression, Anxiety
  • Children
Intervention  ICMJE
  • Drug: Conventional therapy + S (+)-Ketamine

    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.
    Other Names:
    • Conventional therapy + S-ketamine
    • Conventional therapy + Esketamine
  • Drug: Conventional therapy
    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.
    Other Name: Routine treatment
Study Arms  ICMJE
  • Experimental: S (+)-Ketamine group
    Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia.
    Intervention: Drug: Conventional therapy + S (+)-Ketamine
  • Active Comparator: Control group
    Patients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period.
    Intervention: Drug: Conventional therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2021)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Weidong Mi, MD 8613381082966 wwdd1962@aliyun.com
Contact: Hong Wang, MD 8613661363231 301wh@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04834427
Other Study ID Numbers  ICMJE SAFE-SK-C
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weidong Mi, Chinese PLA General Hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE
  • Southern Medical University, China
  • Beijing Children's Hospital
  • Shanghai Children's Medical Center
  • Hunan Children's Hospital
Investigators  ICMJE
Study Chair: Weidong Mi, MD Chinese PLA General Hospital
PRS Account Chinese PLA General Hospital
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP