Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy

Postoperative Pain Clinical Trial

— DTMPCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564603
• Other study ID #: NMU-2579-5FW
• Secondary ID: 06NMUZ028
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2007
• Last updated: April 17, 2008
• Start date: August 2007
• Est. completion date: November 2007

Study information

• Verified date: April 2008
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Nanjing Medical University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Surgeries
• Pain, Postoperative
• Patient-Controlled Analgesia
• Post Operative Analgesia
• Postoperative Pain

Intervention

Drug:
• Dexamethasone Sodium Phosphate Injection
Dexamethasone, 10mg, continuously infused up to 48h after surgeries.

Other:
• 0.9% Saline
Saline, in same volume of 2mL

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Care Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS) of pain		0-48h after surgeries	Yes
Secondary	First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;		0-48h after surgeries	Yes