Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy (DTMPCA)
This study has been completed.
Sponsor:
Nanjing Medical University
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00564603
First received: November 26, 2007
Last updated: April 17, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Pain Post Operative Analgesia Patient-Controlled Analgesia Abdominal Surgeries |
Drug: Dexamethasone Sodium Phosphate Injection Other: 0.9% Saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy |
Resource links provided by NLM:
MedlinePlus related topics:
Hysterectomy
Drug Information available for:
Dexamethasone
Morphine sulfate
Dexamethasone acetate
Dexamethasone sodium phosphate
Sodium phosphate
Sodium phosphate, dibasic
Tramadol
U.S. FDA Resources
Further study details as provided by Nanjing Medical University:
Primary Outcome Measures:
- Visual analog scale (VAS) of pain [ Time Frame: 0-48h after surgeries ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients; [ Time Frame: 0-48h after surgeries ] [ Designated as safety issue: Yes ]
| Enrollment: | 300 |
| Study Start Date: | August 2007 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Saline with same volume added to tramadol infusion combined with morphine PCA.
|
Other: 0.9% Saline
Saline, in same volume of 2mL
|
|
Active Comparator: 2
Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.
|
Drug: Dexamethasone Sodium Phosphate Injection
Dexamethasone, 10mg, continuously infused up to 48h after surgeries.
|
Eligibility| Ages Eligible for Study: | 19 Years to 64 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ASA physical status I-II
- Chinese
- 19-64yr
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564603
Locations
| China, Jiangsu | |
| Nanjing Maternal and Child Care Hospital | |
| Nanjing, Jiangsu, China, 210004 | |
Sponsors and Collaborators
Nanjing Medical University
HRSA/Maternal and Child Health Bureau
Investigators
| Study Director: | XiaoFeng Shen, MD | Nanjing Medical University |
More Information
No publications provided
| Responsible Party: | XiaoFeng Shen, Nanjing Maternal and Child Health Hospital |
| ClinicalTrials.gov Identifier: | NCT00564603 History of Changes |
| Other Study ID Numbers: | NMU-2579-5FW, 06NMUZ028 |
| Study First Received: | November 26, 2007 |
| Last Updated: | April 17, 2008 |
| Health Authority: | China: Ministry of Health China: Nanjing Medical University |
Keywords provided by Nanjing Medical University:
|
Glucocorticoid Opioids Balanced analgesia |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Morphine Tramadol Sodium phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 19, 2013