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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adverse Effect

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