NCT01395901已完成3 期
A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 670
- 试验地点
- 43
- 主要终点
- Proportion of Patients With Complete Response
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient aged from full term neonate to less than 17 years.
- •In-patient or out-patient scheduled to undergo one of the following procedures:
- •ear, nose and throat surgery (e.g., tonsillectomy, adenoidectomy, myringotomy),
- •eye surgery (e.g. strabismus, vitreoretinal, cataract surgery),
- •urological surgery (e.g. orchidopexy, varicocoele),
- •plastic reconstructive surgery (e.g. cleft lip/cleft palate, burn procedures involving the scalp),
- •hernia repair,
- •orthopedic surgery (e.g. foot and ankle deformities, arthroscopic surgeries, ACL surgery),.
- •cardiac surgery,
- •neurosurgery.
- •Patient is scheduled to undergo surgery requiring general intravenous anesthesia
- •Patient is scheduled to receive nitrous oxide during the maintenance phase of anesthesia
- •Patient weighs at least 3.2 kg
- •ASA physical status I, II or III
- •Fertile patients (male or female) must use reliable contraceptive measures
- •Female patients who have attained menarche must have a negative pregnancy test at the screening visit (Visit 1) and at study treatment visit (Visit 2)
- •For patients with known hepatic impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study
- •For patients with known renal impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study
排除标准
- •Lactating females
- •Patient aged ≤6 years who received any investigational drug within 90 days prior to Day 1, or patient aged >6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion.
- •Patient having participated in any previous trial with palonosetron.
- •History of allergy to any components or any other contraindications to the use of any 5-HT3 receptor antagonists
- •Patient to undergo emergency surgery
- •Patient scheduled to receive regional anesthesia (lumbar, epidural, spinal) alone or in conjunction with general intravenous anesthesia
- •Patient scheduled to receive laryngeal mask anesthesia
- •Patient scheduled to receive propofol during the maintenance phase of anesthesia
- •Patient suffering from any concomitant disease uncontrolled by therapy, which, in the judgment of the Investigator, could compromise the outcome of surgery
- •Patient with history of gastro-esophageal reflux (except for patients up to 12 months)
- •Patient with ongoing vomiting from any organic cause
- •Patient having experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug
研究组 & 干预措施
Palonosetron and placebo to Ondansetron
Experimental
Intervention: Drug: Palonosetron
干预措施: Palonosetron (Drug)
Palonosetron and placebo to Ondansetron
Experimental
Intervention: Drug: Palonosetron
干预措施: Placebo to Ondansetron (Drug)
Ondansetron and placebo to Palonosetron
Active Comparator
Intervention: Drug: Comparator: Ondansetron
干预措施: Ondansetron (Drug)
Ondansetron and placebo to Palonosetron
Active Comparator
Intervention: Drug: Comparator: Ondansetron
干预措施: Placebo to Palonosetron (Drug)
结局指标
主要结局
Proportion of Patients With Complete Response
时间窗: 0-24 hours after T0
Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
次要结局
- Proportion of Patients Without Emetic Episodes(0-24 hours after T0)
- Proportion of Patients With no Vomiting(0-24 hours after T0)
- Proportion of Patients Without Antiemetic Rescue Medication(0-24 hours after T0)
- Proportion of Patients Without Nausea (Patient Aged > 6 Years)(0-24 hours after T0)
研究者
研究点 (43)
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