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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00564603
First Posted: November 28, 2007
Last Update Posted: April 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Visual analog scale (VAS) of pain [ Time Frame: 0-48h after surgeries ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 26, 2007
First Posted: November 28, 2007
Last Update Posted: April 21, 2008
Last Verified: April 2008

Keywords provided by Nanjing Medical University:
Glucocorticoid
Opioids
Balanced analgesia

Additional relevant MeSH terms:
Agnosia
Pain, Postoperative
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pain
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Morphine
Tramadol
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action