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NCT04950049 Clinical Trial

The Effect of Dilution and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation

Adverse Effect Clinical Trial

Official title:
The Effect of Dilution With Glucose and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04950049
Other study ID # Zhangyonghai02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 15, 2021
Est. completion date August 31, 2021

Study information
Verified date June 2021
Source General Hospital of Ningxia Medical University
Contact Hanxiang Ma
Phone +86-13519591508
Email mahanxiang@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy of dilution with glucose and prolonged injection time on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).

Description:

Dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given intravenously. The major clinical manifestations are pruritus and pain，and the incidence vary between 38%-71%. Some patients undergo spontaneous remission, while others develop into severe pain or pruritus. In clinical practice, dexamethasone is always diluted with glucose in many cases, but diluted dexamethasone in relieving dexamethasone induced perineal irritation has not been studied yet. The aim of this study was to investigate the efficacy of dilution with glucose on dexamethasone induced perineal irritation.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Aged 18-65 years - ASA physical status I-II Exclusion Criteria: - On regular use of analgesic - Contraindication or allergy to steroid or glucose - Drug or alcohol abuse - Diagnosed with paresthesia or mental diseases - Communication disorders - Pregnancy or nursing

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone
receive 2ml dexamethasone (5mg/ml)
Other:
• Diluted dexamethasone 5ml
receive 5ml dexamethasone (2mg/ml) diluted with 5% glucose
• Diluted dexamethasone 10ml
receive 10ml dexamethasone (1mg/ml) diluted with 5% glucose
• Diluted dexamethasone 20ml
receive 20ml dexamethasone (0.5mg/ml) diluted with 5% glucose

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
General Hospital of Ningxia Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of dexamethasone-induced perineal irritation The investigators record the number of cases of dexamethasone-induced perineal irritation (pain or pruritus) and calculate the incidence During the first 3 min period after the injection of dexamethasone
Secondary Duration of perineal irritation If perineal irritation occurs, the investigators will record its duration After the injection of dexamethasone, up to 5 minutes
Secondary The severity of perineal irritation If perineal irritation occurs, the investigators will assess its severity by using Visual Analogue Scale (the minimum is 0 and the maximum is 10, and the higher scores mean a worse outcome) After the injection of dexamethasone, up to 5 minutes
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