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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adverse Effect

Intervention / Treatment
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* Drug: Dexamethasone
* Other: Diluted dexamethasone 5ml
* Other: Diluted dexamethasone 10ml
* Other: Diluted dexamethasone 20ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 ml dexamethasone (5 mg/ml)<br>50 patients receive 2 ml dexamethasone (5 mg/ml) , the injection time of dexamethasone was less than 2s. | Drug: Dexamethasone<br>* receive 2ml dexamethasone (5mg/ml)<br>|
| Experimental: 5 ml dexamethasone (2mg/ml)<br>50 patients receive 5 ml dexamethasone (2mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s. | Other: Diluted dexamethasone 5ml<br>* receive 5ml dexamethasone (2mg/ml) diluted with 5% glucose<br>|
| Experimental: 10 ml dexamethasone (1mg/ml)<br>50 patients receive 10 ml dexamethasone (1mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s. | Other: Diluted dexamethasone 10ml<br>* receive 10ml dexamethasone (1mg/ml) diluted with 5% glucose<br>|
| Experimental: 20 ml dexamethasone (0.5mg/ml)<br>50 patients receive 20 ml dexamethasone (0.5mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s. | Other: Diluted dexamethasone 20ml<br>* receive 20ml dexamethasone (0.5mg/ml) diluted with 5% glucose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of perineal irritation | If perineal irritation occurs, the investigators will record its duration | After the injection of dexamethasone, up to 5 minutes | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone 21-phosphate, Pain, Pruritus, Glucose