Back to resultsContinuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy (DTMPCA)
Primary Purpose
Postoperative Pain, Post Operative Analgesia, Patient-Controlled Analgesia
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexamethasone Sodium Phosphate Injection
0.9% Saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Glucocorticoid, Opioids, Balanced analgesia
Eligibility 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.
Sites / Locations
- Nanjing Maternal and Child Care Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
1
2
Arm Description
Saline with same volume added to tramadol infusion combined with morphine PCA.
Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.
Outcomes
Primary Outcome Measures
Visual analog scale (VAS) of pain
Secondary Outcome Measures
First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;
Full Information
NCT ID
NCT00564603
First Posted
November 26, 2007
Last Updated
April 17, 2008
Sponsor
Nanjing Medical University
Collaborators
HRSA/Maternal and Child Health Bureau
1. Study Identification
Unique Protocol Identification Number
NCT00564603
Brief Title
Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy
Acronym
DTMPCA
Official Title
Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nanjing Medical University
Collaborators
HRSA/Maternal and Child Health Bureau
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Post Operative Analgesia, Patient-Controlled Analgesia, Abdominal Surgeries
Keywords
Glucocorticoid, Opioids, Balanced analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Saline with same volume added to tramadol infusion combined with morphine PCA.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Sodium Phosphate Injection
Intervention Description
Dexamethasone, 10mg, continuously infused up to 48h after surgeries.
Intervention Type
Other
Intervention Name(s)
0.9% Saline
Intervention Description
Saline, in same volume of 2mL
Primary Outcome Measure Information:
Title
Visual analog scale (VAS) of pain
Time Frame
0-48h after surgeries
Secondary Outcome Measure Information:
Title
First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;
Time Frame
0-48h after surgeries
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternal and Child Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
12. IPD Sharing Statement
Learn more about this trial
Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy
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