The Effect of Dilution and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- Duration of perineal irritation [After the injection of dexamethasone, up to 5 minutes]
If perineal irritation occurs, the investigators will record its duration
- 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
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.- Zhangyonghai02