Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bioavailability of Sufentanil and Ketamine
研究概览
简要总结
The aim of the study is to investigate the absorption and clinical effect of nasal administration of an analgesic nasal spray containing sufentanil+ketamine for pain related to medical procedures in hospitalized children.
详细描述
The management of procedural pain in children ranges from physical restraint to pharmacological interventions. Pediatric formulations that permit accurate dosing, are accepted by children and a have a rapid onset of analgesia are lacking. The objectives were to investigate a pediatric formulation of intranasal sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg for procedural pain and to characterize the pharmacokinetic (PK) profile. Fifty children (≥10 kg) scheduled for a painful procedure were included in this prospective nonrandomized open-label clinical trial. Thirteen of these children had central venous access for drug assay sampling; enabling a compartmental PK analysis using nonlinear mixed-effects models. Pain intensity before and during the procedure was measured using age-appropriate pain scales. Heart rate, oxygen saturation and sedation were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents treated at the University Hospital, Rigshospital
- •Painful medical procedure related to the patients treatment
- •Patient and/or the parents must be able to understand and speak danish
- •Negative pregnancy test for girls, when relevant
- •Signed informed consent
- •Only a light meals or no meals have been ingested 2 hours prior to inclusion
排除标准
- •Allergy to sufentanil or ketamine
- •Abnormal nasal cavity
- •Have been treated with sufentanil and/or ketamine during the last 48 hours
- •Nasal obstruction (rhinitis)
研究组 & 干预措施
Intranasal sufentanil/ketamine
Intranasal combination of sufentanil and ketamine. Dose of sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
干预措施: Intranasal sufentanil/ketamine (Drug)
结局指标
主要结局
Bioavailability of Sufentanil and Ketamine
时间窗: Time= 5-60 min after administration of the investigational medical product
Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine
时间窗: Time=5-60 min after administration of investigational medicinal product
Procedural Pain Intensity Score
时间窗: Pain assessment during painful medical procedure
Children \<5 years old were administered the FLACC (Face Leg Activity Cry Consolability) Scale (Range: 0-10, where 0 is no pain and 10 is worst pain). Children \>= 5 years but \< 8 years old were administered the Visual analog scale modified with six faces by Wong-Baker (Wong-Baker Faces Pain Rating Scale) (Range: 0-10, where 0 is no pain and 10 is worst pain). Children \>= 8 years old were administered a Visual Analog Scale (Range: 0-10, where 0 is no pain and 10 is worst pain).
Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine
时间窗: Time= 5-60 min after administration of the investigational medical product
次要结局
- Acceptance of Intranasal Administration(Immediately after the procedure)
- Sedation Score (UMSS)(Time= 0-70 min. after drug administration)
研究者
Bettina Nygaard Nielsen
M.Sc. Pharm. sponsor contact person
Danish University of Pharmaceutical Sciences