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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Adverse Effect
• Intervention / Treatment: Drug: Dexamethasone; Other: Diluted dexamethasone 5ml; Other: Diluted dexamethasone 10ml; Other: Diluted dexamethasone 20ml

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanxiang Ma; Phone Number: +86-13519591508; Email: mahanxiang@hotmail.com
• Study Contact Backup: Name: Yonghai Zhang; Phone Number: +86-15909508072; Email: zhangyonghai826@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University
• Investigators: Principal Investigator: Yonghai Zhang, General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Pruritus; Glucose; Dexamethasone 21-phosphate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: Zhangyonghai02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No