Trial Outcomes & Findings for Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care (NCT NCT03756038)
NCT ID: NCT03756038
Last Updated: 2020-03-09
Results Overview
Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration
Results posted on
2020-03-09
Participant Flow
Participant milestones
| Measure |
Drug: Oral Lorazepam (1mg)
Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.
|
Drug: Oral Placebo
Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
Baseline characteristics by cohort
| Measure |
Drug: Oral Lorazepam (1mg)
n=1 Participants
Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.
|
Drug: Oral Placebo
Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
n=93 Participants
|
—
|
48 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
—
|
1 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: The item is anchored to pain intensity "right now" at 60 minutes post-study drug administrationPopulation: No one was enrolled in the placebo group because we prematurely halted enrollment due to lack of feasibility
Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)
Outcome measures
| Measure |
Drug: Oral Lorazepam (1mg)
n=1 Participants
Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.
|
Drug: Oral Placebo
Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
|
|---|---|---|
|
Pain Severity in the Emergency Department: Numeric Rating Scale
|
6 units on a scale
|
—
|
SECONDARY outcome
Timeframe: The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.Population: No subjects were enrolled in the placebo group because enrollment was prematurely halted due to lack of feasibility
Positive and Negative Affect Schedule (PANAS)-We will use the 10 items of the Negative Affect Scale; each of these items are scored on a Likert Scale ranging from 1 (very slightly/not at all) to 5 (extremely). The responses for each of the 10 items are summed to create the Negative Affect Score; scores may range from 10-50, with lower scores representing lower scores of negative affect.
Outcome measures
| Measure |
Drug: Oral Lorazepam (1mg)
n=1 Participants
Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.
|
Drug: Oral Placebo
Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
|
|---|---|---|
|
Negative Affect in the Emergency Department
|
10 units on a scale
|
—
|
Adverse Events
Drug: Oral Lorazepam (1mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Drug: Oral Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place