The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

G

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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