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Completed

NCT Number: NCT02768168

The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

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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Key information

Conditions

Adverse Effect Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dezocine

Drug

receive dezocine 0.1 mg/kg

Normal Saline

Other

receive matching placebo (equal volume of normal saline)

Primary outcomes

  1. 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)

    Time frame: In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate

Secondary outcomes

  1. 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)

    Time frame: In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate

Other outcomes

  1. 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)

    Time frame: In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 11, 2016
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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