Intranasal Fentanyl for Procedural Analgesia in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): a Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The purpose of this feasibility clinical trial is to explore the role of intranasal fentanyl for pain associated with PICC placement in preterm infants. The primary goals are identifying whether enough infants join the study and complete the study procedures.
详细描述
Infants admitted to the neonatal intensive care unit (NICU) are subjected to multiple painful procedures as part of clinical care. It is established that early and repeated exposure to pain is associated with negative consequences. However, pain management strategies continue to be underutilized in NICUs worldwide.
Placement of a PICC is a clinically essential painful procedure in infants requiring prolonged intravenous access. The procedure can cause moderate to severe pain. To date, the optimal medication for procedural analgesia during PICC placement is not known.
Intranasal fentanyl has emerged as an option for pain management in infants admitted to the NICU. In preparation for a future definitive clinical trial, this is a feasibility clinical trial exploring the role of intranasal fentanyl for procedural analgesia in preterm infants undergoing PICC placement.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Years 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with a gestational age at birth < 32 weeks or birth weight < 1.5 kg
- •Infants considered medically appropriate for the study by the most responsible physician
排除标准
- •Infants with choanal atresia, nasal mucosal erosion, or epistaxis
- •Infants with facial anomalies
- •Infants diagnosed with genetic conditions known to affect neurological development or severe (grade ≥ III) intraventricular hemorrhage
- •Infants receiving continuous intravenous infusions or scheduled enteral doses of opioids or sedatives within 12 hours of PICC placement
- •Infants with cardiopulmonary instability managed with inotropes, vasopressors, phosphodiesterase enzyme inhibitors, or neuromuscular blocking agents at the time of PICC placement
- •Infants prescribed strong CYP3A4 inhibitors (clarithromycin, itraconazole, ketoconazole, posaconazole, ritonavir, voriconazole) at the time of PICC placement
- •Infants diagnosed with bronchopulmonary dysplasia (need for supplemental oxygen or need for ventilatory support at 36 weeks corrected gestational age)
- •Infants with a previous documented adverse reaction to any formulation of fentanyl
- •Each eligible infant will be enrolled for one PICC placement only during the study period
研究组 & 干预措施
Intranasal fentanyl plus standard of care
One dose of fentanyl 1.5 µg/kg via a mucosal atomization device 10 minutes before the PICC placement.
Standard of care includes sucrose 24% oral solution with or without non-nutritive sucking.
干预措施: Fentanyl (Drug)
Intranasal normal saline plus standard of care
One dose of normal saline (volume equivalent to fentanyl 1.5 µg/kg) via a mucosal atomization device 10 minutes before the PICC placement.
Standard of care includes sucrose 24% oral solution with or without non-nutritive sucking.
干预措施: Normal saline (Drug)
结局指标
主要结局
Recruitment rate
时间窗: 6 month study period
Number of infants assessed for eligibility, number of infants approached for consent, number of enrolled infants, and number of participants completing study procedures
Completeness of data collection for pain score assessment
时间窗: At the needle insertion phase of the PICC placement
Premature infant pain profile-revised (PIPP-R) scores using video recordings. PIPP-R scores range from 0-21 and are interpreted as no pain (score of 0), mild pain (score 1-6), moderate pain (score 7-12), and severe pain (score 13-21).
次要结局
- Number of adverse events(Up to 6 hours after intranasal intervention administration)
- Acceptability and adoption of intranasal medications(Immediately after the PICC placement)