Pain, AcuteESKETAMINENCT05666869
Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement
An observational study of Pain, Acute, run by Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences at 1 site in France.
Trial summary
KETAMINE has been used for several years in emergency departments for analgesic purposes. Its ease of use and its analgesic effect have been demonstrated in several studies. Nevertheless, this molecule is not devoid of side effects, in particular the very frequent occurrence of nausea, vomiting, anxiety, an overall… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Esketamine perfusion
- Type of treatment
- Injection or infusion
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the emergency department of the university hospital of Nice, France (Hôpital Pasteur 2) from monday to friday, 8h30 am to 6h30 pm, meeting the eligibility criteria
Who may be able to join
- Age is 18 years old or more
- Moderate to severe pain as assessed by the patient with a verbal numerical rating scale (NRS) of 6/10 or more ; NRS goes from 0 (no pain) to 10 (the worst pain imaginable)
- Physician has decided to use ESKETAMINE
- Patient is not opposed to enroll in the study after having been informed, as attested by the physician in the patient's file
Who cannot join
- Adult under juridic protection, under guardianship, under curatorship
- Patient unable to express his consent
- Patient deprived of liberty by a judicial or administrative decision
- Pregnant, parturient or nursing mother
- Patients physically or mentally unable to answer the questionnaire
- Typical kidney colic pain
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Nice
Nice, Alpes Maritimes, 06001
Fabien LEMOËL, MD
Shelsea THIBURCE, MD
About this study
KETAMINE has been used for several years in emergency departments for analgesic purposes. Its ease of use and its analgesic effect have been demonstrated in several studies.
Nevertheless, this molecule is not devoid of side effects, in particular the very frequent occurrence of nausea, vomiting, anxiety, an overall feeling of discomfort and more rarely hallucinations, feelings of unreality, or tachycardia.
Read more
Recently, ESKETAMINE, used as an anesthetic but also in the USA as an antidepressant, has obtained its Marketing Authorization in the management of moderate to severe pain. ESKETAMINE corresponds to the S-(-)-KETAMINE enantiomer. Like KETAMINE, it acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor but unlike KETAMINE does not interact, with the sigma receptors responsible for hallucinations and delusional symptoms. ESKETAMINE aimed at anesthetic is about twice as potent as KETAMINE and would also be eliminated more quickly.
Studies suggest that at equivalent doses, ESKETAMINE would be better tolerated than the KETAMINE usually used in emergency departments.
In this study, the tolerance of ESKETAMINE used at analgesic doses for treatment of moderate to severe pain will be assessed in an emergency departement
A wider usage of ESKETAMINE for analgesia purpose in emergency departments is expected, with a better tolerance for the patients compared to KETAMINE
- Conditions
- Pain, Acute
- Being tested
- Esketamine perfusion
- Keywords
- analgesia, emergency department, esketamine
- Medical subject headings
- Acute Pain, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine perfusionDrug
Analgesic dose of ESKETAMINE via a 30 minutes.intravenous perfusion
What is being measured
The primary outcome is the main question the study is designed to answer.
ESKETAMINE adverse reactions
Enumeration of the adverse reactions occuring to the patient as collected by the investigator in the patient file and by the patient in the study questionnaire
Measured: From beginning of perfusion (T0) to patient exit of the emergency department (up to 4 hours after T0)
Secondary outcomes (8)
Pain self assesment T0(a)
Numerical pain rating scale spanning from 0 (no pain) to 10 (the worst pain imaginable)
Measured: beginning of perfusion (T0)
Pain self assesment T0(b)
4 points Likert pain relief scale : completely relieved ; much relieved ; a little relieved ; not relieved at all
Measured: beginning of perfusion (T0)
Pain self assesment T15(a)
Numerical pain rating scale spanning from 0 (no pain) to 10 (the worst pain imaginable)
Measured: 15 minutes after the beginning of perfusion (T0 + 15 minutes)
Pain self assesment T15(b)
4 points Likert pain relief scale : completely relieved ; much relieved ; a little relieved ; not relieved at all
Measured: 15 minutes after the beginning of perfusion (T0 + 15 minutes)
Pain self assesment T30(a)
Numerical pain rating scale spanning from 0 (no pain) to 10 (the worst pain imaginable)
Measured: 30 minutes after the beginning of perfusion (T0 + 30 minutes)
Pain self assesment T30(b)
4 points Likert pain relief scale : completely relieved ; much relieved ; a little relieved ; not relieved at all
Measured: 30 minutes after the beginning of perfusion (T0 + 30 minutes)
Patient satisfaction about his treatment (T15)
Self assessed 3 points Likert satisfaction scale : Very satisfied; Satisfied ; Not satisfied
Measured: 15 minutes after the beginning of perfusion (T0 + 15 minutes)
Patient satisfaction about his treatment (T30)
Self assessed 3 points Likert satisfaction scale : Very satisfied; Satisfied ; Not satisfied
Measured: 30 minutes after the beginning of perfusion (T0 + 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start12 Dec 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Contenti, MD, PhD, Study director, Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666869
- Sponsor's protocol ID
- AFERSAU-2022-01
- Acronym
- ESKETAMINE
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement
- ClinicalTrials.gov ID
- NCT05666869
- Acronym / sponsor ID
- ESKETAMINE / AFERSAU-2022-01
- Conditions
- Pain, Acute
- Keywords
- analgesia, emergency department, esketamine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des UrgencesUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
KETAMINE has been used for several years in emergency departments for analgesic purposes. Its ease of use and its analgesic effect have been demonstrated in several studies.
Nevertheless, this molecule is not devoid of side effects, in particular the very frequent occurrence of nausea, vomiting, anxiety, an overall feeling of discomfort and more rarely hallucinations, feelings of unreality, or tachycardia.
Recently, ESKETAMINE, used as an anesthetic but also in the USA as an antidepressant, has obtained its Marketing Authorization in the management of moderate to severe pain. ESKETAMINE corresponds to the S-(-)-KETAMINE enantiomer. Like KETAMINE, it acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor but unlike KETAMINE does not interact, with the sigma receptors responsible for hallucinations and delusional symptoms. ESKETAMINE aimed at anesthetic is about twice as potent as KETAMINE and would also be eliminated more quickly.
Studies suggest that at equivalent doses, ESKETAMINE would be better tolerated than the KETAMINE usually used in emergency departments.
In this study, the tolerance of ESKETAMINE used at analgesic doses for treatment of moderate to severe pain will be assessed in an emergency departement
A wider usage of ESKETAMINE for analgesia purpose in emergency departments is expected, with a better tolerance for the patients compared to KETAMINE
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the emergency department of the university hospital of Nice, France (Hôpital Pasteur 2) from monday to friday, 8h30 am to 6h30 pm, meeting the eligibility criteria
Key inclusion criteria (4 listed)
- Age is 18 years old or more
- Moderate to severe pain as assessed by the patient with a verbal numerical rating scale (NRS) of 6/10 or more ; NRS goes from 0 (no pain) to 10 (the worst pain imaginable)
- Physician has decided to use ESKETAMINE
- Patient is not opposed to enroll in the study after having been informed, as attested by the physician in the patient's file
Key exclusion criteria (6 listed)
- Adult under juridic protection, under guardianship, under curatorship
- Patient unable to express his consent
- Patient deprived of liberty by a judicial or administrative decision
- Pregnant, parturient or nursing mother
- Patients physically or mentally unable to answer the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esketamine perfusionAnalgesic dose of ESKETAMINE via a 30 minutes.intravenous perfusion | Drug | – |
Primary outcome
ESKETAMINE adverse reactions
Time frame: From beginning of perfusion (T0) to patient exit of the emergency department (up to 4 hours after T0)
Enumeration of the adverse reactions occuring to the patient as collected by the investigator in the patient file and by the patient in the study questionnaire
8 secondary outcomes
Pain self assesment T0(a)
Time frame: beginning of perfusion (T0)
Pain self assesment T0(b)
Time frame: beginning of perfusion (T0)
Pain self assesment T15(a)
Time frame: 15 minutes after the beginning of perfusion (T0 + 15 minutes)
Pain self assesment T15(b)
Time frame: 15 minutes after the beginning of perfusion (T0 + 15 minutes)
Pain self assesment T30(a)
Time frame: 30 minutes after the beginning of perfusion (T0 + 30 minutes)
Pain self assesment T30(b)
Time frame: 30 minutes after the beginning of perfusion (T0 + 30 minutes)
Patient satisfaction about his treatment (T15)
Time frame: 15 minutes after the beginning of perfusion (T0 + 15 minutes)
Patient satisfaction about his treatment (T30)
Time frame: 30 minutes after the beginning of perfusion (T0 + 30 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Contenti, MD, PhD study director
Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Acute, run by Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Contenti, MD, PhD (0492033715 ext. +33, contenti.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ESKETAMINE adverse reactions (time frame: From beginning of perfusion (T0) to patient exit of the emergency department (up to 4 hours after T0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.