Adverse Effect
Conditions
Keywords
Dexamethasone 21-phosphate, Pain, Pruritus, Glucose
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).
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.
Interventions
DRUGDexamethasone
receive 2ml dexamethasone (5mg/ml)
OTHERDiluted dexamethasone 5ml
receive 5ml dexamethasone (2mg/ml) diluted with 5% glucose
OTHERDiluted dexamethasone 10ml
receive 10ml dexamethasone (1mg/ml) diluted with 5% glucose
OTHERDiluted dexamethasone 20ml
receive 20ml dexamethasone (0.5mg/ml) diluted with 5% glucose
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Contacts
Primary ContactHanxiang Ma
Backup ContactYonghai Zhang
Outcome results
None listed