Adverse EffectNCT04950049
The Effect of Dilution and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation
A study testing Dexamethasone, Diluted dexamethasone 5ml and Diluted dexamethasone 10ml in people with Adverse Effect, run by General Hospital of Ningxia Medical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adverse Effect
- What is being tested?
- Dexamethasone, Diluted dexamethasone 5ml and Diluted dexamethasone 10ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2021to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- ASA physical status I-II
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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.
- Conditions
- Adverse Effect
- Being tested
- Dexamethasone, Diluted dexamethasone 5ml, Diluted dexamethasone 10ml, Diluted dexamethasone 20ml
- Keywords
- Dexamethasone 21-phosphate, Pain, Pruritus, Glucose
- Medical subject headings
- Pain, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
receive 2ml dexamethasone (5mg/ml)
Diluted dexamethasone 5mlOther
receive 5ml dexamethasone (2mg/ml) diluted with 5% glucose
Diluted dexamethasone 10mlOther
receive 10ml dexamethasone (1mg/ml) diluted with 5% glucose
Diluted dexamethasone 20mlOther
receive 20ml dexamethasone (0.5mg/ml) diluted with 5% glucose
| Study group | Role | What they receive |
|---|---|---|
| 2 ml dexamethasone (5 mg/ml) | Active comparator | 50 patients receive 2 ml dexamethasone (5 mg/ml) , the injection time of dexamethasone was less than 2s. Receives: Drug: Dexamethasone |
| 5 ml dexamethasone (2mg/ml) | Experimental | 50 patients receive 5 ml dexamethasone (2mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s. Receives: Other: Diluted dexamethasone 5ml |
| 10 ml dexamethasone (1mg/ml) | Experimental | 50 patients receive 10 ml dexamethasone (1mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s. Receives: Other: Diluted dexamethasone 10ml |
| 20 ml dexamethasone (0.5mg/ml) | Experimental | 50 patients receive 20 ml dexamethasone (0.5mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s. Receives: Other: Diluted dexamethasone 20ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the first 3 min period after the injection of dexamethasone
Secondary outcomes (2)
Duration of perineal irritation
If perineal irritation occurs, the investigators will record its duration
Measured: 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)
Measured: After the injection of dexamethasone, up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start15 Jul 2021 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yonghai Zhang, Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950049
- Sponsor's protocol ID
- Zhangyonghai02
- Status last verified
- Jun 2021
- First submitted
- 23 Oct 2020
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dilution With Glucose and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation
- ClinicalTrials.gov ID
- NCT04950049
- Acronym / sponsor ID
- Zhangyonghai02
- Conditions
- Adverse Effect
- Keywords
- Dexamethasone 21-phosphate, Pain, Pruritus, Glucose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 ml dexamethasone (5 mg/ml) | Active comparator | Drug: Dexamethasone50 patients receive 2 ml dexamethasone (5 mg/ml) , the injection time of dexamethasone was less than 2s. |
| 5 ml dexamethasone (2mg/ml) | Experimental | Other: Diluted dexamethasone 5ml50 patients receive 5 ml dexamethasone (2mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s. |
| 10 ml dexamethasone (1mg/ml) | Experimental | Other: Diluted dexamethasone 10ml50 patients receive 10 ml dexamethasone (1mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s. |
| 20 ml dexamethasone (0.5mg/ml) | Experimental | Other: Diluted dexamethasone 20ml50 patients receive 20 ml dexamethasone (0.5mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18-65 years
- ASA physical status I-II
Key exclusion criteria (6 listed)
- On regular use of analgesic
- Contraindication or allergy to steroid or glucose
- Drug or alcohol abuse
- Diagnosed with paresthesia or mental diseases
- Communication disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasonereceive 2ml dexamethasone (5mg/ml) | Drug | 2 ml dexamethasone (5 mg/ml) |
| Diluted dexamethasone 5mlreceive 5ml dexamethasone (2mg/ml) diluted with 5% glucose | Other | 5 ml dexamethasone (2mg/ml) |
| Diluted dexamethasone 10mlreceive 10ml dexamethasone (1mg/ml) diluted with 5% glucose | Other | 10 ml dexamethasone (1mg/ml) |
| Diluted dexamethasone 20mlreceive 20ml dexamethasone (0.5mg/ml) diluted with 5% glucose | Other | 20 ml dexamethasone (0.5mg/ml) |
Primary outcome
The incidence of dexamethasone-induced perineal irritation
Time frame: 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
2 secondary outcomes
Duration of perineal irritation
Time frame: After the injection of dexamethasone, up to 5 minutes
The severity of perineal irritation
Time frame: After the injection of dexamethasone, up to 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yonghai Zhang principal investigator
General Hospital of Ningxia Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone, Diluted dexamethasone 5ml and Diluted dexamethasone 10ml in people with Adverse Effect, run by General Hospital of Ningxia Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanxiang Ma (+86-13519591508, mahanxiang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dexamethasone-induced perineal irritation (time frame: During the first 3 min period after the injection of dexamethasone). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.