The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02768168

Enrollment

Registered

2016-05-11

Start date

2016-05-31

Completion date

2016-07-31

Last updated

2016-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect

Keywords

Dezocine, Dexamethasone 21-phosphate, Pain, Pruritus

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.

Interventions

DRUGdezocine

receive dezocine 0.1 mg/kg

OTHERnormal saline

receive matching placebo (equal volume of normal saline)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Other

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026