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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04834427
• Other study ID #: SAFE-SK-C
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: April 20, 2022
• Est. completion date: December 4, 2024

Study information

• Verified date: March 2024
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3000
• Est. completion date: December 4, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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~?;

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.

Related Conditions & MeSH terms

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

Intervention

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: 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.
• 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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Children's Hospital, Hunan Children's Hospital, Shanghai Children's Medical Center, Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.; 8=Age =17 years: NRS pain score at 2h, 4h, 24h, 48h after surgery.	Hour 0-48 after surgery
Other	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
Other	Time of first rescue analgesia	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.	Hour 0-48 after surgery
Other	The incidence of rescue analgesia	Rescue analgesia refers to the analgesia according to the patient's or guardian's requirements in addition to routine postoperative analgesia.	Hour 0-48 after surgery
Other	Recovery time	The time from the end of the operation to recovery(can be awakened)	Day 0
Other	The incidence of emergence delirium	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.	Day 0
Other	The incidence of unexpected intraoperative events	Unexpected events during operation include intraoperative cough, laryngeal spasm, body movement, tachycardia, decreased oxygen saturation, respiratory depression, bradycardia, hypertension and hypotension.	Intraoperative
Other	The incidence of adverse events 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.	Hour 0-48 after surgery
Other	Children's Depression Inventory(CDI) score	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.	Hour 48 after surgery
Other	Hospital Anxiety and Depression Scale(HAD)score	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.	Hour 48 after surgery
Other	Pharmacoeconomic indicators	Calculating incremental cost-effectiveness ratio (ICER)based on cost-effectiveness analysis.	Hour 48 after surgery
Primary	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
Primary	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
Primary	Opioid consumption	Total opioid consumption(conversion to equivalent morphine)	Hour 0-48 after surgery