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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | receive 2ml dexamethasone (5mg/ml) |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanxiang Ma | Contact | +86-13519591508 | mahanxiang@hotmail.com | |
| Yonghai Zhang | Contact | +86-15909508072 | zhangyonghai826@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Yonghai Zhang | General Hospital of Ningxia Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Diluted dexamethasone 5ml |
| Other |
receive 5ml dexamethasone (2mg/ml) diluted with 5% glucose |
|
| Diluted dexamethasone 10ml | Other | receive 10ml dexamethasone (1mg/ml) diluted with 5% glucose |
|
| Diluted dexamethasone 20ml | Other | receive 20ml dexamethasone (0.5mg/ml) diluted with 5% glucose |
|
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 |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |