Predicting Perioperative Opioid Adverse Effects and Personalizing Analgesia in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Look at polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to see if there is a higher susceptibility to pain and morphine requirement.
研究概览
简要总结
In the United States alone, each year approximately 5 million children undergo painful surgery, many of them experience serious side-effects with opioids and inadequate pain relief. Safe and effective analgesia is an important unmet critical medical need in children and its continued existence is an important perioperative safety and economic problem. Inadequate pain relief and serious side effects from perioperative opioids occur frequently in up to 50% of children. Morphine, the most commonly used perioperative opioid, has a narrow therapeutic index and large inter-patient variations in analgesic response and serious side effects. Frequent inter-individual variations in responses to morphine have significant clinical and economic impact with inadequate pain relief at one end of the spectrum of responses and serious adverse effects such as respiratory depression at the other end. Much of the inter-individual variability in response to a dose of morphine following surgical procedures can be explained by single nucleotide polymorphisms (SNPs) in a subset of the genes that encode proteins involved in pain mechanisms and opioid pathway.
详细描述
Measures and Procedures: Participants will receive standard care, standard anesthetic and an intraoperative dose of morphine per the clinical team.
Research procedures will include:
- Blood draws for genotyping candidate genes and exploratory genes
- Standardized PACU (post anesthesia care unit) Protocol: Subjective pain assessments: Numerical Rating Scale (NRS) 0 to 10. Objective assessment with FLACC (facial expression; leg movement; activity; cry; and consolability) scale, 0-10.
- Significant postoperative pain will be managed in the PACU with rescue doses of morphine and opioids by the clinical team. Analgesic interventions and morphine requirements are collected
- Effects of opioids on pupil measures
- Respiratory response to 5% carbon dioxide preoperatively and postoperatively (first 350 patients only). Another measure of end tidal carbon dioxide will be implemented when the device is clinically available.
- Serial blood draws for morphine pharmacokinetic modeling (through subject #351).
- Opioid adverse effects in PACU and at home.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •boys and girls,
- •3-15 years of age,
- •all races,
- •American Society of Anesthesiologists (ASA) physical status 1,2, and 3,
- •children with history of significant snoring suggestive of obstructive sleep apnea (OSA),
- •Scheduled for tonsillectomy (T) or tonsillectomy and adenoidectomy (T and A).
排除标准
- •allergic to study medications
- •developmental delay,
- •liver and renal diseases,
- •preoperative pain requiring analgesics,
- •children who have problems with pupil or pupillary reaction due to disease
- •preoperative medications influencing pupillary size
- •non-English speaking participants and families
- •Body Mass Index ≥30
- •Participants undergoing additional procedures during surgery
- •Children with certain cardiac conditions
- •Children with severe lung disease
- •Children with a history of seizures currently treated on medication
- •Children with psychiatric/psychological conditions for which patient currently takes medication
结局指标
主要结局
Look at polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to see if there is a higher susceptibility to pain and morphine requirement.
时间窗: After tonsillectomy surgery (duration of post anesthesia care unit stay)
Look at polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to see if there is a relationship to more pain and need for a higher morphine requirement.
次要结局
- Evaluate relationship of pupil reaction and response to 5% carbon dioxide to adverse effects of morphine(After tonsillectomy surgery (duration of post anesthesia care unit stay))
研究者
Senthil Sadhasivam
Professor
University of Pittsburgh