Official Title: “Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Drug: Dexamethasone Sodium Phosphate Injection
  • Dexamethasone, 10mg, continuously infused up to 48h after surgeries.
• Other: 0.9% Saline
  • Saline, in same volume of 2mL

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Saline with same volume added to tramadol infusion combined with morphine PCA.
• Active Comparator: 2
  • Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.

Primary Measures

• Visual analog scale (VAS) of pain
  • Time Frame: 0-48h after surgeries
    Safety Issue?: Yes

Secondary Measures

• First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;
  • Time Frame: 0-48h after surgeries
    Safety Issue?: Yes

Inclusion Criteria:

• 1. ASA physical status I-II
• 2. Chinese
• 3. 19-64yr
• 4. Uterus myoma

Exclusion Criteria:

• 1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
• 2. Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
• 3. 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.
• 4. Those who were not willing to or could not finish the whole study at any time.
• 5. Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nanjing Medical University

Overall Clinical Trial Officials and Contacts

XiaoFeng Shen, MD Study Director Nanjing Medical University  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00564603

Study ID Number: NMU-2579-5FW

ClinicalTrials.gov Identifier: NCT00564603

Health Authority: China: Ministry of Health