The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Adverse Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group D

40 patients receive dezocine 0.1 mg/Kg

Group Type EXPERIMENTAL

dezocine

Intervention Type DRUG

receive dezocine 0.1 mg/kg

Group C

40 patients receive matching placebo （normal saline）

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

receive matching placebo (equal volume of normal saline)

Interventions

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dezocine

receive dezocine 0.1 mg/kg

Intervention Type DRUG

normal saline

receive matching placebo (equal volume of normal saline)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No