Acute PainPhase 2NCT03756038
Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
A Phase 2 study testing Lorazepam in people with Acute Pain, run by Maria Pacella at 2 sites in United States.
Trial summary
In this proposal, the investigators will determine if a single dose of oral lorazepam reduces distress, pain severity, and need for opiate analgesics both in the ED and in the acute recovery period after discharge. The investigators will compare the lorazepam arm to a placebo arm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2019to 27 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 18-65
- Sustained a physical injury with a pain score ≥ 5 on the numeric rating scale [NRS] from 0- 10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable"
- Expected to be in the ED for at least 2 hours, in a private treatment room
- Ownership of a cell phone with text messaging capabilities
- Emergency Department admission assessment confirmed subject is not suicidal.
Who cannot join
- Non-English speaking
- Not medically suitable for lorazepam per treating MD (e.g. medical condition where benzodiazepines are contraindicated or may be unsafe)
- Not alert and oriented
- Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
- Seeking treatment due to a mental health or substance use disorder
- History of chronic opioid use
Show all 13Show fewer
- Prescribed opioid or benzodiazepine use within the past 24 hours
- Alcohol use within the past 12 hours or medical history of alcoholism.
- Clinical indication for open-label benzodiazepine administration in the ED.
- Any use of recreational narcotics throughout lifetime
- Sensitivity or allergy or intolerance to opioids or benzodiazepines
- Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
- Prisoner
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, 15219
About this study
Official title: Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care
In this proposal, the investigators will determine if a single dose of oral lorazepam reduces distress, pain severity, and need for opiate analgesics both in the ED and in the acute recovery period after discharge. The investigators will compare the lorazepam arm to a placebo arm.
Read the detailed description
The investigators will enroll 120 medically stable adult patients who present to two emergency departments with a physical injury (< 24 hours ago) and a chief complaint of pain.
The investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of oral lorazepam (1mg), or 2) oral placebo. Emergency department providers and patients will be blind to treatment allocation.
All participants will complete measures of negative affect and pain scores at baseline, and and 1 and 2 hours post-study drug administration. The investigators will record any analgesics administered in the emergency department until discharge. Patients will also undergo quantitative sensory testing in the Emergency Department at baseline, and after study drug administration. At 14-days post-discharge, the investigators will measure summary reports of pain, mood, and analgesic medication used.
- Conditions
- Acute Pain
- Being tested
- Placebos, Lorazepam
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacebosDrug
In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
LorazepamDrug
Also called Ativan
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Oral Lorazepam (1mg) | Experimental | 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. Receives: Drug: Lorazepam |
| Drug: Oral Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity in the Emergency Department: Numeric Rating Scale
Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)
Measured: The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration
Secondary outcomes (1)
Negative Affect in the Emergency Department
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.
Measured: The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start25 Jan 2019
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Why it stopped: It was not feasible to enroll Emergency Department patients into this protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Pacella
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Physicians, University of Pittsburgh
- Responsible party
- Sponsor-investigator, Maria Pacella, University of Pittsburgh
- Investigators
- Maria L Pacella, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756038
- Sponsor's protocol ID
- PRO18090064
- Status last verified
- Feb 2020
- First submitted
- 26 Nov 2018
- Last updated
- 9 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: here is no plan in place yet because it is undecided whether the research team will need to share the data with investigators/researchers not listed on the protocol.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care
- ClinicalTrials.gov ID
- NCT03756038
- Acronym / sponsor ID
- PRO18090064
- Conditions
- Acute Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was not feasible to enroll Emergency Department patients into this protocol
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Maria PacellaUniversity, hospital or other
- Collaborators
- University of Pittsburgh Physicians, University of Pittsburgh
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Posted 26 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this proposal, the investigators will determine if a single dose of oral lorazepam reduces distress, pain severity, and need for opiate analgesics both in the ED and in the acute recovery period after discharge. The investigators will compare the lorazepam arm to a placebo arm.
Detailed description
The investigators will enroll 120 medically stable adult patients who present to two emergency departments with a physical injury (< 24 hours ago) and a chief complaint of pain.
The investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of oral lorazepam (1mg), or 2) oral placebo. Emergency department providers and patients will be blind to treatment allocation.
All participants will complete measures of negative affect and pain scores at baseline, and and 1 and 2 hours post-study drug administration. The investigators will record any analgesics administered in the emergency department until discharge. Patients will also undergo quantitative sensory testing in the Emergency Department at baseline, and after study drug administration. At 14-days post-discharge, the investigators will measure summary reports of pain, mood, and analgesic medication used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
| Arm | Type | Receives |
|---|---|---|
| Drug: Oral Lorazepam (1mg) | Experimental | Drug: LorazepamLorazepam (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. |
| Drug: Oral Placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults between the ages of 18-65
- Sustained a physical injury with a pain score ≥ 5 on the numeric rating scale [NRS] from 0- 10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable"
- Expected to be in the ED for at least 2 hours, in a private treatment room
- Ownership of a cell phone with text messaging capabilities
- Emergency Department admission assessment confirmed subject is not suicidal.
Key exclusion criteria (13 listed)
- Non-English speaking
- Not medically suitable for lorazepam per treating MD (e.g. medical condition where benzodiazepines are contraindicated or may be unsafe)
- Not alert and oriented
- Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
- Seeking treatment due to a mental health or substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlacebosIn this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients | Drug | Drug: Oral Placebo |
| LorazepamAlso: AtivanThe 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 | Drug: Oral Lorazepam (1mg) |
Primary outcome
Pain Severity in the Emergency Department: Numeric Rating Scale
Time frame: The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration
Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)
1 secondary outcome
Negative Affect in the Emergency Department
Time frame: The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. here is no plan in place yet because it is undecided whether the research team will need to share the data with investigators/researchers not listed on the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria L Pacella, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lorazepam in people with Acute Pain, run by Maria Pacella at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity in the Emergency Department: Numeric Rating Scale (time frame: The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.