Intensive Monitoring Scheme of Lidocaine Cataplasms

Adverse Reaction to Drug Clinical Trial

Official title:

Intensive Monitoring Scheme of Lidocaine Cataplasms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645302
• Other study ID #: ZT-DBN-ZDJC-01
• Status: Recruiting
• Start date: April 6, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Qianfoshan Hospital
• Contact: Wei Xu, MD
• Phone: 17686791319
• Email: weixu[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to obtain complete medication information.

Related Conditions & MeSH terms

• Adverse Reaction to Drug
• Drug-Related Side Effects and Adverse Reactions

Intervention

Drug:
• Lidocaine Cataplasms
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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