NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study. Prestudy to NeoOpioid; No Pain During Infancy by Adapting Off-patent Medicines. EU FP7:HEALTH - 2007-4.2-1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetics; fentanyl clearance
研究概览
简要总结
The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Further cortical, physiological and biochemical responses to fentanyl will be assessed, elucidating the feasibility before the main study project (NeoOpioid) start.
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 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical indication for analgesia before any of following procedures;
- •insertion of peripheral IV-catheter
- •insertion of arterial cannula
- •insertion of chest tube
- •other skin breaking procedure.
- •Possibility to obtain blood samle after the procedure (indwelling line)
- •Infants all gestational ages.
- •Postnatal age 0-28 days
- •Informed written parental concent
排除标准
- •Concurrent or previous opioid administration (72 h interval required)
- •Abdominal surgery
- •Major chromosomal anomaly
- •Neonatal encephalopathy
- •Use of muscle relaxant
- •Hypothermia treatment after hypoxic-ischemic insult
- •Clinical or biochemical evidence of hepatic failure
- •Participation in other intervention trial
研究组 & 干预措施
Fentanyl for procedural pain
A dose of Fentanyl 5 microgram/ml, 0.5 microgram/kg (anticipated medium pain) or 2 microgram/kg (anticipated strong pain) will be given prior to a painful procedure during NICU-care. Repeated doses or complementary analgesics will be administered according to pain assessment and clinical judgement.
This is not an RCT with several arms.
干预措施: Fentanyl (5 microgram/ml) prediluted ampoules (Drug)
结局指标
主要结局
Pharmacokinetics; fentanyl clearance
时间窗: 6 hours
The serum concentration values will be analysed as Area under the curve, AUC
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG)
时间窗: 6 hours
Background activity
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG),
时间窗: 6 hours
Seizure activity
次要结局
- Pharmacodynamics, behavioural response(6 hours)
- Pharmacodynamics, hormonal response(48 hours)
- Pharmacodynamics, change in vital parameters(6 hours)
研究者
Elisabeth Norman
MD, PhD, Senior Consultant
Lund University