The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

General Hospital of Ningxia Medical University

Status: Completed

Conditions: Adverse Effect

Treatments: Other: normal saline; Drug: dezocine

Study type: Interventional

Funder types: Other

Identifiers

NCT02768168

mz2016

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Group D

Experimental group

Description:

40 patients receive dezocine 0.1 mg/Kg

Treatment:

Drug: dezocine

Group C

Placebo Comparator group

Description:

40 patients receive matching placebo （normal saline）

Treatment:

Other: normal saline