Comparison of Intranasal Sufentanil Versus Intravenous Morphine for the Management of Acute Pain
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
This study will be a single-center, randomized, controlled trial conducted in the Brooklyn Hospital Center's Emergency Department (ED) expected to last 2 years. The sample size will be 40 patients with 20 patients in each treatment arm.
The data points to be collected in the study are as follows: baseline characteristics (baseline pain score, date of birth, age, gender, weight and ethnicity), NRS pain scores at 5, 10, 20, and 30 minutes, dose of study treatment administered, incidence of adverse effects, time to patient discharge following administration of study treatment, patient satisfaction of pain control based on a 10-point Likert Scale, number of patients who required rescue analgesia, and amount of rescue analgesia required. 4.
Once informed consent is obtained, patients will be randomized to receive Treatment A (sufentanil 0.7 mcg/kg intranasally (IN) and normal saline 1ml IV push) OR Treatment B (Normal saline 0.6 mL IN and morphine 0.1 mg/kg IV push). It should be noted that during the study period, use of additional morphine or adjuvant analgesics outside of the designated time intervals is allowed. The decision to use adjuvant analgesics is the decision of the attending physician assigned to the patient in the Emergency Department (ED).
详细描述
This study will be a single-center, randomized, controlled trial conducted in the Brooklyn Hospital Center's Emergency Department (ED)
Intervention:
Study participants will be randomized to receive one of the two study treatments below:
-
Treatment A:
-
Sufentanil 0.7 mcg/kg IN x 1dose (max of 1 mL administered per nostril)
-
Normal saline 1ml IV push x 1dose
-
Treatment B:
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, Outcomes Assessor)
盲法说明
Assignment of treatment will be based on randomization. Each patient will be assigned a study number that would correspond to a specific treatment. Only the primary investigator (B.Sin) and the pharmacist procuring the study intervention will be unblinded to the treatment. The physician, nurse, research associate responsible for collecting data, and independent biostatistician responsible for interpreting the data will be blinded. Assignment of treatment will be placed in a opaque envelope where it would be opened only by the pharmacist will who be procuring the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •presenting to emergency department (ED) with chief complaint of acute generalized pain (including abdominal pain, headache, musculoskeletal pain, back pain, flank pain, joint sprains, lacerations, and fractures) with onset of within 6 hours
- •pain score of 5 or greater on numerical pain scale (NRS)
- •provides informed consent
排除标准
- •reported or documented allergy to sufentanil, morphine, fentanyl, alfentanil, remifentanil, hydrocodone, codeine, hydromorphone, levorphanol, oxycodone, or oxymorphone,
- •hemodynamic instability (defined as heart rate not within 60-110bpm
- •respiratory rate not within 12-20 bpm
- •blood pressure not within 90/50-180/100
- •oxygen saturation not within 94-100%)
- •refuse to provide "informed consent" form
- •nasal obstruction/congestion
- •complaint of chest pain
- •recent head trauma/injury
- •past medical history of hepatic impairment (including history of transplant), renal impairment or chronic renal disease (including history of transplant), chronic alcohol abuse, respiratory disease (ie. hypoxia, hypercapnia, COPD),
- •seizure disorder
- •thyroid disorders
- •language barrier or inability to effectively communicate pain
- •weighing > 140 kg
- •pregnancy
- •active breastfeeding.
研究组 & 干预措施
Intranasal sufentanil
Treatment arm to include
- Sufentanil 0.7 mcg/kg intranasal (IN) x 1 dose
- Normal saline 1ml intravenous (IV) push x 1 dose
干预措施: Sufentanil (Drug)
Intranasal sufentanil
Treatment arm to include
- Sufentanil 0.7 mcg/kg intranasal (IN) x 1 dose
- Normal saline 1ml intravenous (IV) push x 1 dose
干预措施: Normal saline (Drug)
Intravenous morphine
b. Treatment B:
- Normal saline 0.3 mL IN x 1 dose
- Morphine 0.1 mg/kg IV push x 1 dose
干预措施: Normal saline (Drug)
Intravenous morphine
b. Treatment B:
- Normal saline 0.3 mL IN x 1 dose
- Morphine 0.1 mg/kg IV push x 1 dose
干预措施: Morphine (Drug)
结局指标
主要结局
Pain score
时间窗: 10 minutes after initiation of study intervention
10 point Numeric Rating Scale will be used to assess pain
次要结局
- Patient satisfaction scores(throughout study period (30 minutes))
- Mean dose of rescue analgesia required(throughout study period (30 minutes))
- Adverse events(throughout study period (30 minutes))
- Number of patients who required rescue analgesia(throughout study period (30 minutes))
- Length of stay(throughout study period (30 minutes))
研究者
Billy Sin
Director, Emergency Medicine Clinical Research Program
The Brooklyn Hospital Center