Ketamine for Pain in the Emergency Department (NCT03896230) | Clinical Trial Compass
TerminatedPhase 4
Ketamine for Pain in the Emergency Department
Stopped: Due to resource limitations the study was on hold and was then terminated.
United States11 participantsStarted 2019-05-03
Plain-language summary
This study will prospectively compare the mean Numerical Rating Scale (NRS) pain score reduction amongst three recommended dosing strategies of intravenous ketamine (0.1 mg/kg, 0.2 mg/kg, and 0.3mg/kg) for acute pain in the emergency department (ED).This study will also examine the frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs. Subgroups for exploratory analysis based on the need for rescue analgesia within two hours of ketamine administration, adequate pain relief, previous opioid tolerance, and age (adults \< 65 years old and \> 65 years old).
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Acute pain (including acute on chronic pain)
* Pain score of moderate to severe (\> 4/10) on the Numerical Rating Scale
* Provider determines the patient requires intravenous ketamine for analgesia
Exclusion Criteria:
* History of hypersensitivity to ketamine
* Altered mental status
* Psychiatric illness
* Known history of renal or hepatic insufficiency
* Acute head or eye injury
* Suspected intracranial hypertension or mass
* Headache as the chief complaint
* Alcohol or drug abuse
* Received an analgesic within the last four hours
* History of congestive heart failure
* History of aortic or brain aneurysm
* Active Chest Pain
* Porphyria
* Active methadone treatment
* Pregnant or breastfeeding
* Signs of respiratory, hemodynamic, or neurologic compromise
* Systolic blood pressure \< 90 mmHg or \> 180 mmHg
* Heart rate \< 50 beats per minute or \> 150 beats per minute
* Respiratory rate \< 10 breaths per minute or \> 30 breaths per minute
* Glasgow Coma Score \< 15
* Previously received ketamine \< 0.3 mg/kg IV for acute pain in the emergency department
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Score
Timeframe: Within 2 hours post infusion completion