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

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ClinicalTrials.gov Identifier: NCT00564603
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : April 21, 2008
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University

Brief 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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 300 participants
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
Study Start Date : August 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007


Arm Intervention/treatment
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.



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

Secondary Outcome Measures :
  1. First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients; [ Time Frame: 0-48h after surgeries ]


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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.

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

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 Posted: November 28, 2007    Key Record Dates
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
Morphine
Tramadol
BB 1101
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