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NCT02768168 Clinical Trial

The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

Adverse Effect Clinical Trial

Official title:
The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02768168
Other study ID # mz2016
Secondary ID
Status Completed
Phase N/A
First received May 9, 2016
Last updated August 2, 2016
Start date May 2016
Est. completion date July 2016

Study information
Verified date August 2016
Source General Hospital of Ningxia Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy of dezocine pretreatment on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).

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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Aged 18-65 years

- ASA physical status I-II

- BMI 18-24.5 kg/m2

Exclusion Criteria:

- On regular use of analgesic

- Contraindication or allergy to steroid or dezocine

- Drug or alcohol abuse

- Diagnosed with paresthesia or mental diseases

- Communication disorders

- Pregnancy or nursing

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• dezocine
receive dezocine 0.1 mg/kg
Other:
• normal saline
receive matching placebo (equal volume of normal saline)

Locations
Country Name City State
China General Hospital of Ningxia Medical University Yinchuan Ningxia

Sponsors (1)
Lead Sponsor Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other 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
Primary 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
Secondary 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
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