The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

Not Applicable

Completed

• Conditions: Adverse Effect
• Interventions: Other: normal saline; Drug: dezocine

• Registration Number: NCT02768168
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief 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).

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. 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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	normal saline	40 patients receive matching placebo （normal saline）
Group D	dezocine	40 patients receive dezocine 0.1 mg/Kg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China