CLINICAL TRIAL

Dexmedetomidine for Chronic Pain

Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether a medication may help reduce pain following surgery.

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About the trial for Chronic Pain

Treatment Groups

This trial involves 2 different treatments. Dexmedetomidine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Dexmedetomidine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo Saline
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
FDA approved

Side Effect Profile for Dexmedetomidine

Dexmedetomidine
Show all side effects
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
Atelectasis
1%
stroke
1%
infection
1%
Hemorrhage
0%
heart failure
0%
seizure
0%
asystol
0%
Transient Ischemic attack
0%
re-intervention
0%
Pulmonary embolism
0%
hypotension
0%
Pneumothorax
0%
Hypoxemia
0%
Myocardial infarction
0%
Cardiogenic shock
0%
Pericardial effusion
Clinically important hypotension
57%
Clinically important bradycardia
9%
Atelectasis
1%
stroke
1%
infection
1%
Hemorrhage
1%
heart failure
0%
seizure
0%
asystol
0%
Transient Ischemic attack
0%
re-intervention
0%
Pulmonary embolism
0%
hypotension
0%
Pneumothorax
0%
Hypoxemia
0%
Myocardial infarction
0%
Cardiogenic shock
0%
Pericardial effusion
0%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02004613) in the Dexmedetomidine ARM group. Side effects include: Clinically important hypotension with 57%, Clinically important bradycardia with 9%, Atelectasis with 1%, stroke with 1%, infection with 1%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Not of childbearing potential
Adults who will undergo lumbar spinal fusion, including surgeries extending into thoracic and sacral segments
Of childbearing potential but is not pregnant at time of surgery as determined by pre-surgical pregnancy testing
If you are in excellent health, your ASA physical status is 1 show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 48 Hours
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 Hours
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 48 Hours.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Dexmedetomidine will improve 1 primary outcome and 2 secondary outcomes in patients with Chronic Pain. Measurement will happen over the course of 6 Weeks.

Numeric Pain Rating Scale (NRS) scores at 6 weeks post surgery
6 WEEKS
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
6 WEEKS
Numeric Pain Rating Scale (NRS) scores during the first 48 hours
48 HOURS
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
48 HOURS
Morphine equivalents used during the first 48 hours after surgery
48 HOURS
Amount of morphine administered during the 48 hours following surgery
48 HOURS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can chronic pain be cured?

The notion that all pain disorders are controllable is an illusion. For the person living with chronic, or otherwise intractable pain, and knowing that nothing can cure their pain, it becomes of utmost importance to understand and be able to live with their situation as it has occurred over an extended period of their life. In fact it is the only way of accepting reality and accepting the situation of the individual for whom this is a perpetual struggle against one’s own needs. The most effective therapy with a successful outcome is one where the individual learns to live with the situation that is happening.

Anonymous Patient Answer

What is chronic pain?

Chronic pain syndromes tend to have both acute, short term, and chronic (long term) components. There is also a link between what chronic pain is and how it is perceived. There is a complex association between both what chronic pain is and how it is perceived. Therefore, chronic pain can be seen as both a physical symptom and an emotional and cognitive one. The complexities of chronic pain suggest the existence of other aspects of chronic pain not investigated or discussed in the available literature.

Anonymous Patient Answer

How many people get chronic pain a year in the United States?

An estimated 3.4 million people in the US will experience chronic pain at some time in their life. Chronic pain is commonly comorbid with other psychopathology and chronic pain is associated with higher medical expenses and reduced employment.

Anonymous Patient Answer

What causes chronic pain?

Although pain is usually present at the time of presentation, its cause is not fully understood. Further research is needed to discover specific causes of pain, because effective patient management is important.

Anonymous Patient Answer

What are common treatments for chronic pain?

The most common treatments for chronic pain are anticonvulsants, antidepressants, and nonsteroidal anti-inflammatory drugs (NSAIDs). A combination of these treatments may be effective for treating chronic pain. Another common treatment is the antidepressant, duloxetine. The use of medications for chronic pain is not always managed effectively; it can be challenging for patients to adhere to medications and to monitor their effects.

Anonymous Patient Answer

What are the signs of chronic pain?

A variety of symptoms can be experienced with [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain), which include dysesthesia, heightened sensitivity to touch or pain, poor posture, and poor muscle tone. These effects can be seen in daily lives but are sometimes overlooked, leading to poor self-image and coping strategies. Some characteristics such as insomnia can affect one's life and the ability to lead an active lifestyle.\n

Anonymous Patient Answer

Who should consider clinical trials for chronic pain?

Although there are many advantages and disadvantages for undertaking clinical trials for Chronic Pain, there are few clinicians who perceive the value in undertaking this research, and there are few organisations to support this kind of research. For clinical trials in Chronic Pain, there needs to be a combination of well-designed research with credible clinical trials. A significant change in the way information from clinical trials is disseminated may help with this. This will require a change in the way evidence for new interventions is assessed, and this will also require a shift in funding priorities.

Anonymous Patient Answer

Have there been other clinical trials involving dexmedetomidine?

Findings from a recent study was limited by its very short duration of the study and may have attracted an unrepresentative study population. We could not assess the patient reported outcome measures of patient-reported physical functioning as they were evaluated by therapists using a validated assessment tool (PPEA). The study could be considered a pilot study that showed some promise in terms of future research. We need to do a larger, more thorough, clinical trial with long-term follow-up to give an accurate result.

Anonymous Patient Answer

How does dexmedetomidine work?

Dexmedetomidine significantly reduces anxiety when added to intravenous opioids during colonoscopy. We think that this effect might be relevant in the acute treatment of colonic motility disorders, but it might be also an important factor in the treatment of pain-related symptoms during endoscopy.

Anonymous Patient Answer

What is the latest research for chronic pain?

While we need to acknowledge the huge number of scientific studies (more than 5000) that support a central role for a 'pain-sensitized central nervous system, particularly involving peripheral pain receptors and pain facilitation and nocicective behaviour, we also acknowledge that these studies are still too few to conclude with enough confidence how a central pain-sensitized CNS interacts with the peripheral pain system and this central and peripheral interaction with other relevant systems. It is also worth noting that current research is limited by the presence of other comorbidities, which must be addressed in future studies.

Anonymous Patient Answer

What are the common side effects of dexmedetomidine?

Dexmedetomidine is a novel non-opioid, fast-acting and short-acting anesthetic. This drug can be used as the routine anesthetic in ophthalmology, ENT, and abdominal surgery. Although there are some concerns about dexmedetomidine, it might be helpful for pain management in ocular surgery.

Anonymous Patient Answer

What is dexmedetomidine?

Dexmedetomidine is an effective yet short-lasting sedating agent for short and long-term pain management during ECT. The duration of sedation after dexmedetomidine administration correlates with the onset of sedation.

Anonymous Patient Answer
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