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

General Hospital of Ningxia Medical University

Status: Unknown

Conditions: Adverse Effect

Treatments: Other: Diluted dexamethasone 20ml; Drug: Dexamethasone; Other: Diluted dexamethasone 10ml; Other: Diluted dexamethasone 5ml

Study type: Interventional

Funder types: Other

Identifiers

NCT04950049

Zhangyonghai02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

2 ml dexamethasone (5 mg/ml)

Active Comparator group

Description:

50 patients receive 2 ml dexamethasone (5 mg/ml) , the injection time of dexamethasone was less than 2s.

Treatment:

Drug: Dexamethasone

5 ml dexamethasone (2mg/ml)

Experimental group

Description:

50 patients receive 5 ml dexamethasone (2mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.

Treatment:

Other: Diluted dexamethasone 5ml

10 ml dexamethasone (1mg/ml)

Experimental group

Description:

50 patients receive 10 ml dexamethasone (1mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.

Treatment:

Other: Diluted dexamethasone 10ml

20 ml dexamethasone (0.5mg/ml)

Experimental group

Description:

50 patients receive 20 ml dexamethasone (0.5mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.

Treatment:

Other: Diluted dexamethasone 20ml