Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy

Nanjing Medical University1 site in 1 country300 target enrollmentAugust 2007

ConditionsPostoperative Pain Post Operative Analgesia Patient-Controlled Analgesia Abdominal Surgeries

Interventions0.9% Saline Dexamethasone Sodium Phosphate Injection

DrugsDexamethasone Sodium Phosphate Injection

Overview

Phase: Phase 4
Intervention: 0.9% Saline
Conditions: Postoperative Pain
Sponsor: Nanjing Medical University
Enrollment: 300
Locations: 1
Primary Endpoint: Visual analog scale (VAS) of pain
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v. basal infusion of tramadol is a certified technique in postoperative pain management. We purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine is an effective way in treating postoperative pain.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

November 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Nanjing Medical University

Eligibility Criteria

Inclusion Criteria

•ASA physical status I-II
•Uterus myoma

Exclusion Criteria

•Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
•Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
•Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
•Those who were not willing to or could not finish the whole study at any time.
•Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.

Arms & Interventions

1

Saline with same volume added to tramadol infusion combined with morphine PCA.

Intervention: 0.9% Saline

2

Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.

Intervention: Dexamethasone Sodium Phosphate Injection

Outcomes

Primary Outcomes

Visual analog scale (VAS) of pain

Time Frame: 0-48h after surgeries

Secondary Outcomes

First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;(0-48h after surgeries)