Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy - Full Text View

Sponsor:	Nanjing Medical University
Collaborator:	HRSA/Maternal and Child Health Bureau
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00564603

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 IV

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 Sodium phosphate, dibasic Tramadol Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

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 February 12, 2012