Clinical trial NCT05603975: Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study
Official title: Analgesic Effect of Esketamine in Dressing Change for Severe Burns in Adults: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Burns
Keywords: Analgesia
Burn dressing change
Esketamine
Fentanyl
Adverse events
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Grades II to IV
* Patients with severe degree burns Ages 18 to 60
* Patients who signed informed consent forms

Exclusion Criteria:

* 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

Primary outcomes:
measure: The dosage of the remedy fentanyl
timeFrame: Within 5 minutes after the dressing change
Secondary outcomes:
measure: SF-MPQ score after awakening
timeFrame: Within 15 minutes to 30 minutes after the patient wakes up
measure: Incidence of sedation-related complication
timeFrame: From the beginning of the medication to the end of the dressing change, assessed up to 30 minute.
measure: Resuscitation time
timeFrame: From the end of the dressing change to the patient's Ramsay Sedation Scale was 1, assessed up to 10 minute.
measure: Incidence of early depression
timeFrame: 3 days after dressing change
measure: Incidence of nausea and vomiting
timeFrame: 1 days after dressing change
measure: Proportion of patients taking fentanyl remedies
timeFrame: Within 5 minutes after the dressing change
measure: Patient satisfaction with dressing changes
timeFrame: 30 minutes to 1 hour after the patient wakes up
measure: Burn physician satisfaction with the procedure
timeFrame: Within 5 minutes after the end of the dressing change
measure: Incidence of serious complications associated with burns
timeFrame: 15 days after dressing change
Other outcomes:
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