A Randomized Trial of Intranasal Fentanyl Versus Placebo as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage in the Emergency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS) Pain Score at Baseline
研究概览
简要总结
This randomized clinical trial aims to compare the analgesic efficacy of intranasal fentanyl to placebo as analgesic adjunct to conventional local anesthesia for the treatment of pain of the overall procedure in adult patients undergoing lidocaine infiltration and subsequent abscess incision and drainage in the Emergency Department (ED).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting to the ED for an abscess requiring incision and drainage
- •ED attending physician's judgment that the patient has capacity to provide informed consent.
- •Patients must be able to understand English or Spanish.
排除标准
- •Use of opioids or tramadol within past 7 days.
- •Prior adverse reaction or allergy to opioids.
- •Patients who are pregnant
- •Patients weight > 100kg
- •Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
- •Medical condition that might affect metabolism or opioid analgesics such as cirrhosis (Child Pugh A or worse) or kidney impairment (CKD 3 or worse)
- •Chronic malnutrition, severe hypovolemia (dehydration of blood loss) or hepatic disease
- •Alcohol intoxication: history of alcoholism or the presence of alcohol intoxication as judged by the treating physician may alter pain perception and has previously increased adverse events.
- •SBP <100 mmHg: Opioids can produce peripheral vasodilation causing orthostasis.
- •HR < 60/min: Opioids can cause bradycardia.
- •Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
- •Use of MAO inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
- •Patients using transdermal pain patches or oral opioid use > 10 days in the prior month: frequent opioid use may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments.
- •Patients with a history of traumatic brain injury, seizures or hallucinations
- •Patients with anatomical anomalies or medical conditions precluding intranasal administration
研究组 & 干预措施
Intranasal fentanyl
2 mcg/kg INF, administered via intranasal route by atomizer syringe
干预措施: Intranasal fentanyl (Drug)
Placebo
0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe
干预措施: Placebo (Drug)
结局指标
主要结局
Numerical Rating Scale (NRS) Pain Score at Baseline
时间窗: Baseline
Patient reported pain scores at baseline. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
NRS Pain Score After Lidocaine Injection
时间窗: Following Lidocaine injection measured once anytime up to 12 minutes after intranasal administration
Patient reported NRS pain scores after Lidocaine injection. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
NRS Pain Score Following Incision
时间窗: Measured once anytime up to 60 minutes following intranasal administration
Patient reported NRS pain scores following Incision. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
NRS Pain Score After Blunt Dissection
时间窗: Measured once anytime up to 60 minutes following intranasal administration
Patient reported NRS pain scores after Blunt Dissection. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
NRS Pain Score After Irrigation
时间窗: Measured once anytime up to 60 minutes following intranasal administration
Patient reported NRS pain scores after Irrigation. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
NRS Pain Score After Packing of Abscess
时间窗: Measured once at the time of completion of application of the bandage, up to 60 minutes following intranasal administration
Patient reported pain after Packing of abscess. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
Numerical Rating Scale (NRS) Pain Score for Overall Procedure
时间窗: Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration
Patient reported pain scores for overall Procedure assessed immediately after placement of dressing at the end of procedure. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
次要结局
- Patient Satisfaction With Analgesia(120 minutes)
- Health Care Providers Reported Perception of Study Medication Compared to Usual Care(120 minutes)