AnalgesiaNCT05603975
Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study
A study testing Esketamine 0.1mg/kg intravenous injection and Normal saline in people with Analgesia and Burns, run by Shenzhen Second People's Hospital.
Trial summary
Patients with severe and above degree burns are often complicated with inhalation injury and systemic infection. During debridement and dressing change in such patients, doctors will be more cautious in using analgesics. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Esketamine 0.1mg/kg intravenous injection and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 31 May 2025
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Grades II to IV
- Patients with severe degree burns Ages 18 to 60
- Patients who signed informed consent forms
Who cannot join
- Hepatic and renal insufficiency
- Allergy to intended medication
- History of antidepressant or antipsychotic drug use
- Atrioventricular block of second degree or higher
- Patients who can't cooperate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analgesic Effect of Esketamine in Dressing Change for Severe Burns in Adults: a Prospective Randomized Controlled Study
Patients with severe and above degree burns are often complicated with inhalation injury and systemic infection. During debridement and dressing change in such patients, doctors will be more cautious in using analgesics. Patients often moan, shiver and limb movement due to insufficient sedation and analgesia, resulting in unpleasant feelings and experiences, which increases the anxiety of patients during hospitalization. Previous studies have shown that the use of ketamine in burn patients during dressing change can produce good analgesia and maintain stable vital signs.
Esketamine, the dextral monomer of ketamine, has hypnotic, sedative and analgesic effects and could be safely used in clinical anesthesia. Compared with ketamine, esketamine has stronger analgesic efficacy and less circulatory influence, which is more consistent with the characteristics of ideal analgesic drugs in burn dressing. As an FDA-approved drug for the treatment of refractory depression, esketamine has potential social benefits in burn patients due to its rapid antidepressant pharmacological properties. This study hypothesized that esketamine could reduce the pain of dressing change in patients with severe burns and reduce the occurrence of early depression in such patients.
Read more
This study adopted a prospective, double-blind, randomized, controlled, single-center design. A total of 52 severe burn patients aged 18-60 years who need debridement and dressing change under sedation and analgesia were included and randomly divided into the experiment group: esketamine would be used in the induction phase; the control group: esketamine would not be used in the induction phase. Both groups were given dexmedetomidine and butofinol before induction, and fentanyl as a remedy during the dressing change phase. The dosage of fentanyl in the dressing change phase, the pain score (SF-MPQ) after recovery, the incidence of sedation-related complication were compared between the two groups.
This study explores the advantages of esketamine in reducing the use of opioids and the pain score of patients.
- Being tested
- Esketamine 0.1mg/kg intravenous injection, Normal saline
- Keywords
- Analgesia, Burn dressing change, Esketamine, Fentanyl, Adverse events
- Medical subject headings
- Agnosia, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine 0.1mg/kg intravenous injectionDrug
The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change.
Normal salineDrug
Also called Normal saline 0.1ml/kg intravenous injection
The "Normal saline" was administered intravenously at 0.1ml per kilogram of body weight 1min before the dressing change.
| Study group | Role | What they receive |
|---|---|---|
| EsKetamine Group | Active comparator | The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change.
Esketamine Hydrochloride Injection 2ml：50mg Receives: Drug: Esketamine 0.1mg/kg intravenous injection |
| Control Group | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dosage of the remedy fentanyl
Observe the dose of syringe solution
Measured: Within 5 minutes after the dressing change
Secondary outcomes (9)
SF-MPQ score after awakening
Evaluate Short-Form McGill Pain Questionnaire (SF-MPQ). The SF-MPQ is a highly reliable and sensitive instrument used to asses and measure pain levels. The minimum is 0 and the maximum is 60, with a higher score indicating more severe pain.
Measured: Within 15 minutes to 30 minutes after the patient wakes up
Incidence of sedation-related complication
The data collector observes and ticks the type of complication
Measured: From the beginning of the medication to the end of the dressing change, assessed up to 30 minute.
Resuscitation time
The data collector observed, filled in the end time of the dressing change and the time when the patient's Ramsay Sedation Scale was 1.
Measured: From the end of the dressing change to the patient's Ramsay Sedation Scale was 1, assessed up to 10 minute.
Incidence of early depression
Evaluate Hospital Anxiety Depression
Measured: 3 days after dressing change
Incidence of nausea and vomiting
Data collectors obtain data on the occurrence of events through patient or caregiver records
Measured: 1 days after dressing change
Proportion of patients taking fentanyl remedies
The proportion used is calculated from the data record
Measured: Within 5 minutes after the dressing change
Patient satisfaction with dressing changes
Data collectors assessed patients using the VAS satisfaction score. The minimum is 0 and the maximum is 10, with a higher score indicating higher level of satisfaction.
Measured: 30 minutes to 1 hour after the patient wakes up
Burn physician satisfaction with the procedure
Data collectors assessed physician using the VAS satisfaction score. The minimum is 0 and the maximum is 10, with a higher score indicating higher level of satisfaction.
Measured: Within 5 minutes after the end of the dressing change
Incidence of serious complications associated with burns
Collect data through electronic medical records
Measured: 15 days after dressing change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhiHeng Liu, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603975
- Sponsor's protocol ID
- 20223357006
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research protocol will be announced later in the plan.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Esketamine in Dressing Change for Severe Burns in Adults: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05603975
- Acronym / sponsor ID
- 20223357006
- Keywords
- Analgesia, Burn dressing change, Esketamine, Fentanyl, Adverse events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 3 Nov 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.
Patients with severe and above degree burns are often complicated with inhalation injury and systemic infection. During debridement and dressing change in such patients, doctors will be more cautious in using analgesics. Patients often moan, shiver and limb movement due to insufficient sedation and analgesia, resulting in unpleasant feelings and experiences, which increases the anxiety of patients during hospitalization. Previous studies have shown that the use of ketamine in burn patients during dressing change can produce good analgesia and maintain stable vital signs.
Esketamine, the dextral monomer of ketamine, has hypnotic, sedative and analgesic effects and could be safely used in clinical anesthesia. Compared with ketamine, esketamine has stronger analgesic efficacy and less circulatory influence, which is more consistent with the characteristics of ideal analgesic drugs in burn dressing. As an FDA-approved drug for the treatment of refractory depression, esketamine has potential social benefits in burn patients due to its rapid antidepressant pharmacological properties. This study hypothesized that esketamine could reduce the pain of dressing change in patients with severe burns and reduce the occurrence of early depression in such patients.
This study adopted a prospective, double-blind, randomized, controlled, single-center design. A total of 52 severe burn patients aged 18-60 years who need debridement and dressing change under sedation and analgesia were included and randomly divided into the experiment group: esketamine would be used in the induction phase; the control group: esketamine would not be used in the induction phase. Both groups were given dexmedetomidine and butofinol before induction, and fentanyl as a remedy during the dressing change phase. The dosage of fentanyl in the dressing change phase, the pain score (SF-MPQ) after recovery, the incidence of sedation-related complication were compared between the two groups.
This study explores the advantages of esketamine in reducing the use of opioids and the pain score of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EsKetamine Group | Active comparator | Drug: Esketamine 0.1mg/kg intravenous injectionThe "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change. Esketamine Hydrochloride Injection 2ml：50mg |
| Control Group | Placebo comparator | Drug: Normal saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) Grades II to IV
- Patients with severe degree burns Ages 18 to 60
- Patients who signed informed consent forms
Key exclusion criteria (5 listed)
- Hepatic and renal insufficiency
- Allergy to intended medication
- History of antidepressant or antipsychotic drug use
- Atrioventricular block of second degree or higher
- Patients who can't cooperate
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 0.1mg/kg intravenous injectionThe "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change. | Drug | EsKetamine Group |
| Normal salineAlso: Normal saline 0.1ml/kg intravenous injectionThe "Normal saline" was administered intravenously at 0.1ml per kilogram of body weight 1min before the dressing change. | Drug | Control Group |
Primary outcome
The dosage of the remedy fentanyl
Time frame: Within 5 minutes after the dressing change
Observe the dose of syringe solution
9 secondary outcomes
SF-MPQ score after awakening
Time frame: Within 15 minutes to 30 minutes after the patient wakes up
Incidence of sedation-related complication
Time frame: From the beginning of the medication to the end of the dressing change, assessed up to 30 minute.
Resuscitation time
Time frame: From the end of the dressing change to the patient's Ramsay Sedation Scale was 1, assessed up to 10 minute.
Incidence of early depression
Time frame: 3 days after dressing change
Incidence of nausea and vomiting
Time frame: 1 days after dressing change
Proportion of patients taking fentanyl remedies
Time frame: Within 5 minutes after the dressing change
Patient satisfaction with dressing changes
Time frame: 30 minutes to 1 hour after the patient wakes up
Burn physician satisfaction with the procedure
Time frame: Within 5 minutes after the end of the dressing change
Incidence of serious complications associated with burns
Time frame: 15 days after dressing change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No. The research protocol will be announced later in the plan.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine 0.1mg/kg intravenous injection and Normal saline in people with Analgesia and Burns, run by Shenzhen Second People's Hospital.
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 3 inclusion and 5 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Zhiheng Liu, Dr (+8615818505570, 15818505570@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dosage of the remedy fentanyl (time frame: Within 5 minutes after the dressing change). 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 3 Nov 2022.