Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the efficacy of dezocine pretreatment 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. Dezocine, a new synthetic opiate agonist-antagonist, has been used for the treatment of pain and pruritus, but its role in relieving dexamethasone induced perineal irritation has not been studied yet. The aim of this study was to investigate the efficacy of dezocine pretreatment on dexamethasone induced perineal irritation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group D | Experimental | 40 patients receive dezocine 0.1 mg/Kg |
|
| Group C | Placebo Comparator | 40 patients receive matching placebo （normal saline） |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dezocine | Drug | receive dezocine 0.1 mg/kg |
| |
| normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo) | In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate |
| Measure | Description | Time Frame |
|---|---|---|
| The severity of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo) | In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo) | In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Junwei Zheng | General Hospital of Ningxia Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 26, 2016 | |
| Reset | Nov 14, 2016 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 26, 2016 | Nov 14, 2016 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C010827 | dezocine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
receive matching placebo (equal volume of normal saline) |
|
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |