Assessment of the Analgesic Efficacy and Tolerability of the Perioperative Association of the Ketamine With Opiates After Posterior Vertebral Fusion Surgery in Children With Idiopathic Scoliosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cumulative Consumption of Epidural Morphine at 72h Postoperatively
研究概览
简要总结
Comparison of the Efficacy of ketamine measuring the total consumption of morphine in pediatric patients with idiopathic scoliosis
详细描述
A randomized unicenter clinical trial, parallel, double-blind study, placebo-controlled group.
Involve the participation of Pediatric patients, aged between 11 and 18 years, of both genders, diagnosed with idiopathic scoliosis and posterior spinal fusion surgery candidates included in the Anesthesia Physical Classification System (ASA) 1 or 2 classes.
Both groups received remifentanil at doses of 0.3 mcg / Kg / min before surgical procedure and a bolus of 150 mcg / Kg of morphine hydrochloride, approximately 60 minutes before extubation, followed by PCA morphine hydrochloride administration.
The patients in the experimental group are treated with a combination of ketamine, remifentanil hydrochloride and morphine while the control group will be treated with a combination of saline, remifentanil and morphine hydrochloride.
Treatment of patients in the study is initiated during the induction of anesthesia and ends at the hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders diagnosed with idiopathic scoliosis aged between 8 and 18 years old.
- •Patients of both genders diagnosed with idiopathic scoliosis and candidates for vertebral fusion corrective surgery with instrumentation.
- •Patients with ASA 1 or ASA
- •Patients and/or parents/tutors consent to participate in the clinical trial.
排除标准
- •Patients with chronic preoperative pain.
- •Patients with addiction to narcotics.
- •Patients with a history of allergy, contraindication or intolerance to the drugs used.
- •Patients unable to understand the patient-controlled analgesia system.
- •Patients with mental disorders.
- •Reoperated patients.
- •Patients requiring elective postoperative ventilation.
- •Pregnant patients.
研究组 & 干预措施
Ketamine Hydrochloride
Received a combination of ketamine, remifentanil and morphine hydrochloride established by the following dosage regimen:
- KETAMINE HYDROCHLORIDE 0,5mg/Kg Intravenous bolus administered during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation
- during surgery remifentanil 0,3 mcg / kg / min.
- at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively.
干预措施: Ketamine Hydrochloride (Drug)
Ketamine Hydrochloride
Received a combination of ketamine, remifentanil and morphine hydrochloride established by the following dosage regimen:
- KETAMINE HYDROCHLORIDE 0,5mg/Kg Intravenous bolus administered during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation
- during surgery remifentanil 0,3 mcg / kg / min.
- at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively.
干预措施: Remifentanil (Drug)
Ketamine Hydrochloride
Received a combination of ketamine, remifentanil and morphine hydrochloride established by the following dosage regimen:
- KETAMINE HYDROCHLORIDE 0,5mg/Kg Intravenous bolus administered during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation
- during surgery remifentanil 0,3 mcg / kg / min.
- at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively.
干预措施: Morphine hydrochloride (Drug)
Placebo
Received a combination of physiological serum, remifentanil and morphine hydrochloride established by the following dosage regimen:
- 0,9 % physiological serum 0,5mg/Kg administered by an intravenous (IV) line during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation
- during surgery remifentanil 0.3 mcg / kg / min.
- at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively.
干预措施: Placebo (Other)
Placebo
Received a combination of physiological serum, remifentanil and morphine hydrochloride established by the following dosage regimen:
- 0,9 % physiological serum 0,5mg/Kg administered by an intravenous (IV) line during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation
- during surgery remifentanil 0.3 mcg / kg / min.
- at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively.
干预措施: Remifentanil (Drug)
Placebo
Received a combination of physiological serum, remifentanil and morphine hydrochloride established by the following dosage regimen:
- 0,9 % physiological serum 0,5mg/Kg administered by an intravenous (IV) line during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation
- during surgery remifentanil 0.3 mcg / kg / min.
- at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively.
干预措施: Morphine hydrochloride (Drug)
结局指标
主要结局
Cumulative Consumption of Epidural Morphine at 72h Postoperatively
时间窗: in the first 72 hours postoperatively
For the assessment of the related ketamine analgesic efficacy. Cumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 0,3 mcg/kg/min until the surgery operation and 150mcg/Kg of Morphine hydrochloride 60min before extubation
次要结局
- Rates of significant adverse events(every 4 hours from the begin until the end of the surgical operation)
- Change From Baseline in Pain by sensorial test using the Voy Frey filament(in the first 72 hours post surgery)
- Change From Baseline in neuropathic pain using Douleur Neuropathique en 4 Questions (DN4) questionnaire(at week 6 and after 3 and 6 months post surgery.)
- Time to oral tolerability(up to 6 months from the end of the surgical operation)
- Time to First Postoperative Ambulation(up to 6 months from the end of the surgical operation)
- Change From Baseline in Pain Scores (Visual Analogue Scale)(at week 6 and after 3 and 6 months post surgery.)
- Time to postoperative recovery(up to 6 months from the end of the surgical operation)