Organ Protective Effect of Cetirizine In Patients With Severe Burns

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Burns

Treatments: Drug: Cetirizine; Drug: Midazolam and Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT06126991

RuijinH_20230318

Details and patient eligibility

About

This prospective clinical trial aims to investigate the organ protective effects of cetirizine in patients with severe burns.

Full description

This is a prospective, randomized, single-blind, parallel-controlled clinical trial. The global objective is to compare the organ protective effects of the sedation and analgesia regimen (midazolam, fentanyl) with the modified sedation and analgesia regimen (midazolam, fentanyl, cetirizine) in patients with severe burns (≥30% TBSA). Participants will receive the intervention from admission to 72 hours post-burn. Researchers will take the APACHE II scores on days 7 after admission as the main outcomes. Researchers will also take other supplementary examination results into account, including liver enzyme, myocardial enzyme, renal function, haemodynamic index, coagulation function, and pulmonary interstitial edema.

Enrollment: 32 estimated patients

Sex: All

Ages: 12 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent form
• Commitment to comply with the procedures and cooperation during the course
• TBSA >30% and admitted within the first day after burns
• No severe compound injuries

Exclusion criteria

• History of allergy to drugs in the trial
• Postoperative complications that would interfere with the observation
• Mental illness and severe heart disease, hypertension
• Serious genetic diseases
• Incomplete clinical information (unclear diagnosis, incomplete medical history, incomplete medication records, etc.)
• Pregnancy/lactation
• Malignant tumors
• Organ insufficiency due to previous chronic diseases such as hypertension, diabetes mellitus or non-burning factors
• Serious adverse reactions
• Self-requested withdrawal

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

The Modified Sedation and Analgesia Regimen Group

Experimental group

Description:

midazolam, fentanyl, cetirizine

Treatment:

Drug: Cetirizine

Drug: Midazolam and Fentanyl

The Sedation and Analgesia Regimen Group

Active Comparator group

Description:

midazolam, fentanyl

Treatment:

Drug: Midazolam and Fentanyl