ESKetamine Low-dose vs Ketamine Low-dose for Severe Acute Pain in Emergency Units, Comparison of PsychodyslEptic Effects

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of two different medications, esketamine and low-dose ketamine, on managing severe acute pain in patients who come to the emergency department. Severe pain is defined as a score of 6 or higher on a scale from 0 to 10. The goal is to see which medication is more effective and better tolerated by patients. Esketamine is believed to be more effective for pain relief and may have fewer psychological side effects compared to low-dose ketamine, but this has not yet been tested in emergency settings.

To participate in the trial, you must be an adult (18 years or older) experiencing severe acute pain and able to provide informed consent. Certain conditions, like pregnancy, severe heart problems, or previous substance abuse, may exclude you from joining. If you decide to participate, you will receive either esketamine or low-dose ketamine in a controlled environment, and the medical team will monitor your experience closely. This study aims to find safer and more effective ways to manage severe pain while reducing the need for opioids, which can be problematic.

Gender

ALL

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.