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

Not Applicable

• Conditions: Adverse Effect
• Interventions: Other: Diluted dexamethasone 20ml; Other: Diluted dexamethasone 10ml; Other: Diluted dexamethasone 5ml; Drug: Dexamethasone

• Registration Number: NCT04950049
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief 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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-10-23
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-30
• Last Update Submitted: 2021-06-30
• Study First Posted: 2021-07-06
• Last Update Posted: 2021-07-06
• Study Start: 2021-07-15
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Aged 18-65 years
• ASA physical status I-II

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 ml dexamethasone (0.5mg/ml)	Diluted dexamethasone 20ml	50 patients receive 20 ml dexamethasone (0.5mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.
10 ml dexamethasone (1mg/ml)	Diluted dexamethasone 10ml	50 patients receive 10 ml dexamethasone (1mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.
5 ml dexamethasone (2mg/ml)	Diluted dexamethasone 5ml	50 patients receive 5 ml dexamethasone (2mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.
2 ml dexamethasone (5 mg/ml)	Dexamethasone	50 patients receive 2 ml dexamethasone (5 mg/ml) , the injection time of dexamethasone was less than 2s.

Primary Outcome Measures

Name	Time	Method
The incidence of dexamethasone-induced perineal irritation	During the first 3 min period after the injection of dexamethasone	The investigators record the number of cases of dexamethasone-induced perineal irritation (pain or pruritus) and calculate the incidence

Secondary Outcome Measures

Name	Time	Method
Duration of perineal irritation	After the injection of dexamethasone, up to 5 minutes	If perineal irritation occurs, the investigators will record its duration
The severity of perineal irritation	After the injection of dexamethasone, up to 5 minutes	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)