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Sponsors and Collaborators: |
Nanjing Medical University HRSA/Maternal and Child Health Bureau |
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Information provided by: | Nanjing Medical University |
ClinicalTrials.gov Identifier: | NCT00564603 |
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 |
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Postoperative Pain Post Operative Analgesia Patient-Controlled Analgesia Abdominal Surgeries |
Drug: Dexamethasone Sodium Phosphate Injection Other: 0.9% Saline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy |
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 |
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1: Placebo Comparator
Saline with same volume added to tramadol infusion combined with morphine PCA.
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Other: 0.9% Saline
Saline, in same volume of 2mL
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2: Active Comparator
Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.
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Drug: Dexamethasone Sodium Phosphate Injection
Dexamethasone, 10mg, continuously infused up to 48h after surgeries.
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Ages Eligible for Study: | 19 Years to 64 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China, Jiangsu | |
Nanjing Maternal and Child Care Hospital | |
Nanjing, Jiangsu, China, 210004 |
Study Director: | XiaoFeng Shen, MD | Nanjing Medical University |
Responsible Party: | Nanjing Maternal and Child Health Hospital ( XiaoFeng Shen ) |
Study ID Numbers: | NMU-2579-5FW, 06NMUZ028 |
Study First Received: | November 26, 2007 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00564603 |
Health Authority: | China: Ministry of Health; China: Nanjing Medical University |
Glucocorticoid Opioids Balanced analgesia |
Dexamethasone Morphine Signs and Symptoms Sodium phosphate Postoperative Complications |
Tramadol Pain Dexamethasone acetate Pain, Postoperative |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Cathartics |
Glucocorticoids Hormones Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |