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临床试验/NCT03464461
NCT03464461终止4 期

Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
289
试验地点
1
主要终点
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type

研究概览

简要总结

The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.

详细描述

Patients from 4 groups will be treated with 3 different doses of ketorolac. The groups are 1. headache 2. abdominal pain 3. musculo-skeletal pain 4. viral syndrome. The doses will be 0, 10, 30mgs of ketorolac to clarify the placebo effect and the optimal dosage as a function of condition.

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
Double (Participant, Care Provider)

盲法说明

blinded drug

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • pregnant allergic other contraindication

研究组 & 干预措施

0 mg

Placebo Comparator

0 mg ketorolac - placebo

干预措施: Ketorolac (Drug)

10 mg

Active Comparator

10 mg ketorolac - low dose ketorolac

干预措施: Ketorolac (Drug)

30 mg

Active Comparator

30 mg ketorolac - usual dose ketorolac

干预措施: Ketorolac (Drug)

结局指标

主要结局

Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type

时间窗: 30 minutes

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain

时间窗: 30 minutes

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache

时间窗: 30 minutes

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain

时间窗: 30 min

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain

时间窗: 30 min

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Robinson

Associate Professor

University of Missouri-Columbia

研究点 (1)

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Dosing of Ketorolac in the Emergency Department | 临床试验