Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT06943404
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years and ≤ 65 years of age
* Admitted to ED within 24 hours of MVC
* Anticipated to be discharged home from the ED
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Consent to receive unencrypted communications
* Has a smartphone with continuous service for ≥ 1 year
* Has a personal email address they regularly access
* Able to speak and read English
* PTS prediction tool risk score ≥ 16 in the ED
* Females of childbearing potential (not surgically sterilized (tubal ligation/hysterectomy) or not post-menopausal (no menstrual period for \> 6 months)) must be willing to use a medically acceptable and effective birth control method for 3 months before the study and while participating in the study. Medically acceptable methods of contraception that may be used by the participant include abstinence, birth control pills or patches, birth control implants, diaphragm, intrauterine device (IUD), or condoms.
Exclusion Criteria:
* Substantial comorbid injury (e.g., long bone fracture)
* People of childbearing potential who are pregnant, breastfeeding, planning to become pregnant, or not using a highly effective form of contraception (e.g., implants, intrauterine devices (IUDs), tubal ligation, hormonal birth control pills, patches, vaginal rings, or injections) during their participation
* Prisoner status
* Chronic daily opioid use prior to MVC (\> 20 mg oral daily morphine equivalents)
* Bipolar disorder, psychotic disorder, active psychosis, suicidal ideation, or homicidal ideation
* Plans for hospital admission
* Clinically significant history of cardiac disease including (a) history of syncope or other syncopal attacks; (b) current evidence of orthostatic hypotension (defined as a decrease in systolic BP of 20 mm Hg or decrease in diastolic BP of 10 mm Hg within 3 minutes); (c) resting heart rate of \<55 beats per minute; (d) systolic blood pressure \<110 mm Hg or diastolic BP \<70 mm Hg; (e) participants with a corrected QT interval (QTc) interval \>440msec (males) or \>460msec (females) not in sinus rhythm; or 1st, 2nd or 3rd degree hearth block; or (f) history of severely impaired ventricular function (ejection fraction \< 30%).
* Hypomagnesia (\<1.7 mg/dL) or hypokalemia (\< 3.0 Milliequivalents (mEq/L))
* Substantial hepatic impairment (e.g. Aspartate Transaminase (AST) or Alanine Transaminase (ALT) \> 3 times the upper limit of normal or history of cirrhosis).
* Currently taking the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation including sedative/hypnotics, barbiturates, antihistamines, sedative antidepressants (e.g. doxepin, mirtazapine, trazodone), and triptans (e.g., sumatriptan); c) alpha-2-adrenergic agonists (clonidine, guanfacine, lofexidine); d) or adrenergic agents prescribed for other reasons (prazosin). (Permitted Concomitant Medications: The concomitant medications allowed in the study include non-sedative antidepressants used to treat PTSD)
* Hypersensitivity or history of allergic reaction to dexmedetomidine
* Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06943404
Study Brief:
Protocol Section:
NCT06943404