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

NCT ID: NCT04950049

Last Updated: 2021-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2021-08-31

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.

Conditions

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Adverse Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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2 ml dexamethasone (5 mg/ml)

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

receive 2ml dexamethasone (5mg/ml)

5 ml dexamethasone (2mg/ml)

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

Group Type EXPERIMENTAL

Diluted dexamethasone 5ml

Intervention Type OTHER

receive 5ml dexamethasone (2mg/ml) diluted with 5% glucose

10 ml dexamethasone (1mg/ml)

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

Group Type EXPERIMENTAL

Diluted dexamethasone 10ml

Intervention Type OTHER

receive 10ml dexamethasone (1mg/ml) diluted with 5% glucose

20 ml dexamethasone (0.5mg/ml)

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

Group Type EXPERIMENTAL

Diluted dexamethasone 20ml

Intervention Type OTHER

receive 20ml dexamethasone (0.5mg/ml) diluted with 5% glucose

Interventions

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Dexamethasone

receive 2ml dexamethasone (5mg/ml)

Intervention Type DRUG

Diluted dexamethasone 5ml

receive 5ml dexamethasone (2mg/ml) diluted with 5% glucose

Intervention Type OTHER

Diluted dexamethasone 10ml

receive 10ml dexamethasone (1mg/ml) diluted with 5% glucose

Intervention Type OTHER

Diluted dexamethasone 20ml

receive 20ml dexamethasone (0.5mg/ml) diluted with 5% glucose

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yonghai Zhang

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Ningxia Medical University

Central Contacts

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Hanxiang Ma

Role: CONTACT

+86-13519591508

Yonghai Zhang

Role: CONTACT

+86-15909508072

Other Identifiers

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Zhangyonghai02

Identifier Type: -

Identifier Source: org_study_id

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