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

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04950049
Collaborator
(none)
200
Enrollment
4
Arms
1.5
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Dexamethasone
  • Other: Diluted dexamethasone 5ml
  • Other: Diluted dexamethasone 10ml
  • Other: Diluted dexamethasone 20ml
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
The Effect of Dilution With Glucose and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation
Anticipated Study Start Date :
Jul 15, 2021
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Aug 31, 2021

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Duration of perineal irritation [After the injection of dexamethasone, up to 5 minutes]

    If perineal irritation occurs, the investigators will record its duration

  2. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • General Hospital of Ningxia Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier:
NCT04950049
Other Study ID Numbers:
  • Zhangyonghai02
First Posted:
Jul 6, 2021
Last Update Posted:
Jul 6, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by General Hospital of Ningxia Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2021