Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jason McMullan
Age
18–65
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Intranasal Ketamine as an Adjunct to Fentanyl for the Prehospital Treatment of Acute Traumatic Pain
