Intensive Monitoring Scheme of Lidocaine Cataplasms

NCT05645302 | Unknown FDA Drug

• 1 other identifier: ZT-DBN-ZDJC-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In this center, retrospective research methods are used to collect data. Patients who had used Lidocaine Cataplasms at least once were included consecutively. Taking the time when the patient first used Lidocaine Cataplasms as the starting time (the study baseline), collect the demographic characteristics of the patient, the medication scheme of Lidocaine Cataplasms and other information, as well as the medication safety and other information from the first medication to the end of medication or discharge (whichever occurs first).

Conditions

Adverse Reaction to Drug

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Past medical history and other diseases that the researcher thinks have clinical significance. Collect the frequency, type, years, etc. of drinking and/or smoking, as well as the family history of diseases. Including white blood cell, red blood cell, hemoglobin, platelet count, etc. Including white blood cells, red blood cells, urine protein, urine sugar, etc. Including ALT, AST, ALP, TBil, GGT, BUN, Cr, etc. The researcher issued a prescription of lidocaine gel plaster according to the drug instructions, and recorded the indications, medication time, dose, frequency, drug batch number, etc. It includes all kinds of reactions unrelated to the treatment purpose during the study period, including symptoms, signs, laboratory abnormalities with clinical significance or special examinations.administration or discharge.

  January 1, 2021 - April 1, 2022

Study Arms (1)

Patients using Lidocaine Cataplasms

Drug: Lidocaine Cataplasms

Interventions

Lidocaine Cataplasms DRUG

The main ingredient of this product is lidocaine, the cream surface is white or almost white, the cream is evenly spread on the back, and the cream surface is covered with film.

Patients using Lidocaine Cataplasms

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have used Lidocaine Cataplasms at least 1 consecutive time between January 1, 2021 and April 1, 2022.

You may qualify if:

• All patients receiving Lidocaine Cataplasms from January 1, 2021 to April 1, 2022.

You may not qualify if:

• Unable to obtain complete medication information.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Central Study Contacts

Wei Xu, MD

CONTACT

17686791319; weixu@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 9, 2022
• Study Start: April 6, 2022
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-11

Locations

CN (1)