Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients

Zhejiang University

Status and phase: Unknown; Phase 4

Conditions: Burns

Treatments: Drug: Esketamine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04682782

2020-516

Details and patient eligibility

About

This study aim to determine whether a small-dose esketamine infusion can be used for pain control in severe burn patients, and thereby reduce the total intra-operative opioid requirement. Secondary objectives are to determine whether this low-dose esketamine infusion will increase the stability of circulation.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All intubated adult burn patients( age>18 ), presenting to the operating room;
• Burn area> 30%.

Exclusion criteria

• Allergy to Esketamine or benzodiazepines
• Esketamine or ketamine use in the preceding 24 hours
• Increased intracranial pressure
• Increased intraocular pressure
• Porphyria
• Thyroid disorders
• Seizures
• Acute myocardial ischemia
• Children (patients under age 18), prisoners, pregnant or breastfeeding women, patients with psychosis, patients with developmental delay, and any condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the trial endpoints.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

Esketamine

Experimental group

Description:

Participants randomized to this arm will receive Esketamine (1 mg/ml) infused at 0.1 mg/kg/hour (0.1 ml/kg/h) throughout the operation

Treatment:

Drug: Esketamine

Saline

Placebo Comparator group

Description:

Participants randomized to this arm will receive 0.9 mg/ml sodium chloride, infused at a rate of 0.1 ml/kg/hour throughout the operation

Treatment:

Drug: Saline