Comparing Esketamine and Ketamine for Severe Acute Pain in Emergency Departments

Etude randomisée contrôlée en Double-aveugle ESKAPE : ESKétamine Low-dose Versus kétamine Low-dose Pour la Douleur Aiguë sévère Aux Urgences, Comparaison Des Effets PsychodyslEptiques

This study is testing whether low doses of esketamine or ketamine can help adults in the emergency department manage severe pain better than traditional opioid treatments.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (Academic / other)
• Locations: 1 site (Nice, Alpes-maritimes)
• Trial ID: NCT06853041 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effects of low-dose esketamine and low-dose ketamine on severe acute pain management in emergency department patients. With a focus on patients experiencing pain rated 6 or higher on a numerical scale, the study seeks to evaluate the efficacy and safety of these alternatives to traditional opioid treatments. The trial will involve adult patients who provide informed consent and are experiencing acute pain due to medical or traumatic conditions. By exploring these alternatives, the study aims to address the challenges of opioid use and the need for rapid pain relief in overcrowded emergency settings.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and over who are experiencing severe acute pain in an emergency department setting.

Not a fit: Patients who are unable to quantify their pain score or have a history of drug addiction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more efficient method for managing severe acute pain without relying heavily on opioids.

How similar studies have performed: Previous studies have shown promising results with low-dose ketamine for pain management, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Adult patients aged 18 or over,
* consulting our emergency department for a medical or traumatic pathology responsible for acute (less than 7 days old) and severe pain (greater than or equal to 6 on the Verbal Numerical Rating Scale, which has 11 levels from 0 = no pain to 10 = maximum imaginable pain).
* Free and informed consent given before the start of the trial.
* Patients affiliated to social security system.

Exclusion Criteria:

* Inability to quantify pain score ;
* proven or suspected intoxication (drug or alcohol) leading to consciousness disorders (Glasgow score less than or equal to 15) ;
* person under legal protection or deprived of liberty ;
* pregnant or breast-feeding patients ;
* known allergy to ketamine or esketamine ;
* history of drug addiction or dependence ;
* insufficiently controlled hyperthyroidism ;
* history of cerebral of myocardial infarction ;
* known severe heart failure ;
* existence of intracranial hypertension, glaucoma or ocular trauma ;
* unstable vital signs (systolic blood pressure \< 90 mmHg or \> 180, heart rate \< 50 per minute or \> 150, respiratory rate \< 10 per minute or \> 30) ;
* chronic treatment with aminophylline, theophylline or methylergometrine ;
* administration of morphine or another opioid within one hour of inclusion ;
* ongoing simultaneous participation in another study that could interfere with the treatment studied or the results of statistical analysis.

Where this trial is running

Nice, Alpes-maritimes

• CHU de NICE — Nice, Alpes-maritimes, France (Recruiting)

Study contacts

• Study coordinator: Fabien LEMOEL, PH

Conditions Acute Pain