Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change in Pain Score 20 Minutes After Administration of Study Drug
研究概览
简要总结
The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.
详细描述
Principles of therapy for treatment of vaso-occlusive crises include early aggressive analgesic therapy with opiates and non-steroidal anti-inflammatory agents as well as fluid administration. It is known that there is a significant delay in time to administration of analgesics in children with VOC in the ED. The most easily modifiable factor that contributes to delayed opiate administration is route of administration.
Intranasal medication administration is an easy, rapid way to administer opiates with minimal discomfort as well as bypassing first past metabolism and the blood brain barrier. Intranasal fentanyl has been shown to be a safe and effective analgesic for treatment of acute pain in children, reaching therapeutic effect in 2-10 minutes after administration.
The investigators believe that intranasal fentanyl therapy will be able to provide expedited and effective pain therapy to patients with sickle cell disease presenting to the pediatric emergency department with a vaso-occlusive crisis
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
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sickle Cell Disease
- •Ages 3 years - 21 years
- •Exclusion Criteria for Enrollment:
- •Pregnancy
- •Known allergy to Fentanyl
- •Usage of daily home opiates
- •Exclusion Criteria at presentation in ED with a painful crisis:
- •Wong Baker FACES Pain Score <6
- •Systolic blood pressure < 5 percentile for age
- •Oxygen saturation <92% on room air
- •Temperature > 102°F
- •Respiratory distress
- •Isolated abdominal pain
- •Isolated headache
- •New neurological symptoms
- •Severe rhinorrhea or epistaxis
- •History of trauma
- •Pregnancy
排除标准
- 未提供
研究组 & 干预措施
Intranasal Saline
干预措施: Normal Saline (Drug)
Intranasal Fentnayl
干预措施: Fentanyl Citrate (Drug)
结局指标
主要结局
Change in Pain Score 20 Minutes After Administration of Study Drug
时间窗: Baseline and 20 minutes after administration of study drug
Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively. To calculate the change, the reported pain score at 20 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 20 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 20 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 20 minutes) representing a INCREASE in pain between the two time points.
次要结局
- Presence of Bradycardia(Every 5 minutes until 30 minutes after study drug administration)
- Presence of Headache(Participants will be followed for the duration of their ED visit, an expected average of 6 hours)
- Admission Rate(This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage)
- Length of Stay in ED(Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours)
- Total Amount of Narcotics Administered(Participants will be followed for the duration of their ED visit, an expected average of 6 hours)
- Time to Study Drug Administration(Time from triage to adminstration of study drug)
- Change in Pain Score at 10 Minutes(Baseline and 10 minutes after administration of study drug)
- Change in Pain Score at 30 Minutes(Baseline and 30 minutes after administration of study drug)
- Change in Pain Score(Baseline and immediately prior to IV insertion)
- Respiratory Distress(Every 5 minutes until 30 minutes after study drug administration)
- Hypotension(Every 5 minutes until 30 minutes after study drug administration)
- Hypoxia(Every 5 minutes until 30 minutes after study drug administration)
研究者
Daniel Marc Fein
Assistant Professor of Pediatrics
Montefiore Medical Center