Please select the eligibility criteria that correspond to the clinical trial below.
Title: Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
Brief Summary: The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries.


Options:
A: Adult males with acute traumatic pain that are eligible to receive pain medication prior to hospital arrival under current practice will be screened for enrollment in the primary trial. The inclusion and exclusion criteria mirror this existing protocol (Appendix 1: Prehospital Protocols).

Inclusion Criteria of Primary Trial

* Subjects must be experiencing pain due to acute trauma (i.e. extremity deformity, tourniquet placement, or severe burns).
* A Verbal Numerical Rating Scale pain score ≥7 prior to any pain medication administration.
* Age: ≥18 through 65 years (i.e. subjects must have had their 18th birthday, but not had their 66th birthday).
* Systolic blood pressure ≥100mmHg and \<180mmHg.
* Transported directly from the scene of injury to the Emergency Department at University of Cincinnati Medical Center by a participating EMS agency.
* English-speaking.
* Male sex.
* Receiving fentanyl IV/IM/IN as part of standard care. Exclusion Criteria of Primary Trial
* Subject reported allergy to morphine, fentanyl, or ketamine.
* EMS treatment with ketamine (any), morphine (any), or more than one dose of fentanyl prior to enrollment.
* Inter-facility transfers.
* Prisoners or those in police custody.
* Female sex.
* Paramedic clinical concern of acute agitation or psychosis.
* Pain medication not needed in judgment of prehospital provider.
* Altered level of consciousness, mental status change, or suspected head injury.
* Paramedic clinical concern of circulatory shock.
* Inability to provide Verbal Numerical Rating Scale.
* Facial injury or suspicion of nasal bone fracture.
* Paramedic judgment that subject cannot consent due to underlying cognitive impairment.
* Systolic blood pressure ≥180mmHg

Justification for Exclusions Medications are generally withheld if there is a reported drug allergy. This is a study of acute pain management, and pretreatment with additional medications may bias results. EMS does not routinely provide inter-facility (between hospital) transfers, and these subjects will likely be transferred several hours after injury and should have received pain medications from the original hospital. Prisoners or those in police custody represent a protected population. Ketamine is pregnancy class N (unknown); while frequently used in developing countries for analgesia/sedation for Cesarean sections, 73-75 obtaining a serum or urine pregnancy test is not possible in the prehospital setting. Breast feeding women and women of childbearing age will be excluded. To avoid introducing bias from a partially included population, all women will be excluded. Ketamine may cause psychomotor agitation in some subjects (even though ketamine is frequently used as treatment of excited delirium76). Pre-existing agitation or mental status changes and inability to provide VNRS prevent outcomes assessments. Current prehospital protocols do not allow pain medications for patients with circulatory shock. Nasal trauma may interfere with medication delivery or absorption. Previous trials have excluded patients with a systolic blood pressure ≥180mmHg.6,38,49

Inclusion Criteria for Secondary Trial Subjects enrolled in the primary trial will be approached for participation in the secondary trial. Enrollment in the secondary trial will involve a second and separate consent process (further described below). Participation in the secondary trial is not required to participate in the primary trial.
B: Inclusion Criteria:

1. 18 plus years
2. A native Japanese speaking ability
3. Possibility to contact patients with injury in 240 hours, and dosing in oral use
4. Physical and metal status to possible understands scope and contents in the trial and gets informed consent

Exclusion Criteria:

1. Clearly irretrievable acute brain parenchyma damage and subdural or subarachnoidal bleeding detected by computed tomography and/or magnetic resonance imaging
2. Cognitive impairment: Mini Mental State Examination \< 24
3. Heavy drinker or 100IU/L ≦ γGTP in administration
4. Heavy smoker (over 40 cigarettes per day)
5. History and current suspicion in diagnosis of psychosis and bipolar I disorder
6. Suspicion in diagnosis of alcoholic, substance-related disorder and eating disorder
7. Existence of marked serious symptoms such as suicidal ideation, self-harm behavior, dissociation, status of need rapidly psychiatric treatment
8. Use of anti-epilepsy drug, lithium, ethyl icosapentate and anti-coagulant drug (for example, aspirin, warfarin, etc) within 3 month at regular intervals
9. Use of polyunsaturated fatty acid supplement within 3 month at regular intervals
10. Habit of eating fish over 4 times per week
C: Inclusion Criteria:

1. Persons over the age of 21, who have been exposed to an event meeting the DSM-IV "A.1" criterion for trauma exposure, expressing marked anxiety, and/ or emotional distress and/or dissociation, as assessed by the Visual Analog Scales
2. Who provide written, informed consent to participate in the study.

Exclusion Criteria:

1. Physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by Abbreviated Injury Scale (AIS), or by clinical judgment;
2. Head injury involving confusion, loss of consciousness, or amnesia;
3. Medical conditions such as extreme obesity, psoriasis, herpes, Cushing's syndrome, current infectious disease, current viral disease, tuberculosis, unstable diabetes or hypertension, myasthenia gravis, and heart failure. Persons taking medications that can interfere with the HPA axis (e.g.,steroids, betablockers,indomethacin) will be excluded;
4. Weight below 45 or above 120 kg.
5. Pregnancy (in suggestive cases, a pregnancy test will be performed);
6. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.
7. Overt psychopathology, intoxication, or under the influence of substances.
8. Evidence or history of schizophrenia, bipolar, other psychotic condition;
9. Prior history of PTSD;
10. Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure;
11. Assessed serious suicide risk.
D: Inclusion Criteria:

1. Males and females aged 18-90 years with multiple-trauma or head trauma admitted to the ICU.
2. Enteral nutrition can be initiated within 36 hours of admission/ injury.
3. Mechanical ventilation.

Exclusion criteria:

1. Severe underlying systemic disease and /or treatment with immunosuppressive agents.
2. Contra-indication for Enteral Nutrition (mechanical or functional bowel. obstruction, high-output fistula, severe necrotizing pancreatitis).
3. 2nd /3rd degree burns covering \> 66% BSA.
4. Pregnancy.
5. Participants under the age of 18.

Answer: B