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

Sponsors and Collaborators:	Nanjing Medical University 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:	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

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy Surgery

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
1: Placebo Comparator Saline with same volume added to tramadol infusion combined with morphine PCA.	Other: 0.9% Saline Saline, in same volume of 2mL
2: Active Comparator 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:	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 History of Changes
Health Authority:	China: Ministry of Health; China: Nanjing Medical University

Keywords provided by Nanjing Medical University:

Glucocorticoid
Opioids
Balanced analgesia

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Morphine
Antineoplastic Agents, Hormonal
Tramadol
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Cathartics
Pain

Glucocorticoids
Hormones
Signs and Symptoms
Laxatives
Sodium phosphate
Postoperative Complications
Peripheral Nervous System Agents
Pain, Postoperative
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Cathartics
Pain
Hormones
Glucocorticoids

Pharmacologic Actions
Signs and Symptoms
Sodium phosphate
Pathologic Processes
Postoperative Complications
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Dexamethasone acetate

ClinicalTrials.gov processed this record on July 02, 2009