| November 26, 2007 |
| April 17, 2008 |
| August 2007 |
| November 2007 (final data collection date for primary outcome measure) |
| Visual analog scale (VAS) of pain [ Time Frame: 0-48h after surgeries ] [ Designated as safety issue: Yes ] |
| Visual analog scale (VAS) of pain [ Time Frame: 0-48h after surgeries ] |
| Complete list of historical versions of study NCT00564603 on ClinicalTrials.gov Archive Site |
| 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 ] |
| First requirement of morphine;
Total morphine consumption;
VAS sedation;
VAS satisfaction;
Side effects;
Overall conditions of patients; [ Time Frame: 0-48h after surgeries ] |
| |
| Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy |
| Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Postoperative Pain
- Post Operative Analgesia
- Patient-Controlled Analgesia
- Abdominal Surgeries
|
- Drug: Dexamethasone Sodium Phosphate Injection
- Other: 0.9% Saline
|
- Placebo Comparator: Saline with same volume added to tramadol infusion combined with morphine PCA.
- Active Comparator: Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.
|
| |
| |
| Completed |
| 300 |
| November 2007 |
| November 2007 (final data collection date for primary outcome measure) |
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.
|
| Female |
| 19 Years to 64 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| China |
| |
| NCT00564603 |
| XiaoFeng Shen, Nanjing Maternal and Child Health Hospital |
| NMU-2579-5FW, 06NMUZ028 |
| Nanjing Medical University |
| HRSA/Maternal and Child Health Bureau |
| Study Director: |
XiaoFeng Shen, MD |
Nanjing Medical University |
|
|
| Nanjing Medical University |
| April 2008 |
