Intranasal Ketamine Versus Subcutaneous Ketamine for Treatment of Post-traumatic Acute Pain in th… (NCT05229055) | Clinical Trial Compass
CompletedPhase 2/3
Intranasal Ketamine Versus Subcutaneous Ketamine for Treatment of Post-traumatic Acute Pain in the Emergency Department ( INVESCK )
Tunisia1,000 participantsStarted 2023-04-15
Plain-language summary
Pain is the most common complaint for emergency department (ED) visit. Intranasal ketamine has been shown to provide rapid, well-tolerated, effective analgesia to emergency department (ED) patients with acute pain. few trials have studied ketamine infusion subcutaneously for pain management in trauma patients.
Who can participate
Age range
18 Years – 60 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:
* • Patients who presented to the ED with acute limb trauma pain with a visual analgesic scale (VAS) of 5 or more on a standard 11 point (0-10).
* Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb.
Exclusion Criteria:
* Pregnancy/Breastfeeding
* altered mental status (GCS\<15)
* Allergy to ketamine or morphine
* Weight less than 40 kg or greater than 100kg
* Unstable vital signs (systolic blood pressure \<90 or \> 180mmHg, pulse rate\<50 or \>150bpm, and respiration rate \<10 or \>30 breath/min)
* Medical history of acute head or eye injury
* Medical history of seizure
* Medical history of intracranial hypertension,
* Medical history of chronic pain,
* Medical history of severe renal or hepatic insufficiency.
* Medical history of glaucoma
* Alcohol or drug abuse
* Psychiatric illness,
* Recent (4 hours before) analgesic agent use.
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.
1This trial compared intranasal ketamine to subcutaneous ketamine for acute pain in the emergency department — since it's now completed, has the data been published, and what did the results show about which route worked better at that 30-minute mark?
2The trial tracked severe adverse events as a primary outcome — what kinds of serious side effects were they watching for with ketamine, and how does that safety profile compare to the pain medications I'm currently being offered?
3This was a Phase 2/3 trial, which means it was still building evidence on both effectiveness and safety — does that affect how confident my care team would be in using ketamine this way compared to more established treatments for my acute pain?
4Since the study used a specific target of cutting pain scores by more than 50% within 30 minutes, is that kind of rapid relief realistic for my situation, and is intranasal ketamine even available or practical in the emergency setting I'd be seen in?
5Are there standard pain management options that are already well-established that I should consider first, before thinking about approaches that were still being studied in a trial like this one?
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
VAS decrease of more than 50% comparing to initial value at 30 minutes following analgesia administration