NCT01012999终止1 期
Pain Control and Patient Satisfaction: a Dosing Study to Determine a Safe and Effective Dose of Intra-nasal Sufentanil to Treat Emergency Department Patients With Moderate to Severe Pain Due to Extremity Trauma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pain Relief at Thirty Minutes
研究概览
简要总结
The purpose of this study is to determine the appropriate dose and effectiveness of intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to severe pain due to broken bone(s) in the arm or leg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older;
- •isolated traumatic injury to upper or lower extremity;
- •alert and oriented to name, date, place; patient has a numeric pain score of 5 or higher;
- •speaks English as their primary language;
- •female patients are on birth control, menopausal, or are sterile (hysterectomy, tubal ligation)
排除标准
- •injury isolated to a finger or toe;
- •previous nasal or sinus surgery; chronic nasal problem;
- •acute nasal problem (ie epistaxis, upper respiratory infection, sinusitis);
- •pregnant; prisoner; allergy to sufentanil, fentanyl, or alfentanil; history of analgesic abuse or dependency;
- •presence of other painful injuries; systolic Blood Pressure less than 100 mm Hg;
- •patient seems or is confused or has a head injury; room air oxygenation less than 95%;
- •patient has chronic obstructive pulmonary disease, severe asthma, oxygen-dependent pulmonary disease;
- •impaired hepatic or renal function (obtained clinically or by history);
- •weight more than 230 lbs (100 kg);
- •alcohol or drug intoxication (per patient admission or clinical assessment of physician);
- •elderly (> 70 years)
研究组 & 干预措施
Intranasal sufentanil, pain relief
Experimental
Intranasal sufentanil administered at a dose of 0.5 mcg/kg times one dose at beginning of thirty minute period
干预措施: sufentanil (Drug)
结局指标
主要结局
Pain Relief at Thirty Minutes
时间窗: 30 min post dose
Measured pain relief on a visual analog scale (0-10- ten being the worst pain and zero being no pain at all).
次要结局
未报告次要终点
研究者
Robert Stephen, MD
Associate Professor
University of Utah
研究点 (1)
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