Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy
Information source: Nanjing Medical University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain; Post Operative Analgesia; Patient-Controlled Analgesia; Abdominal Surgeries
Intervention: Dexamethasone Sodium Phosphate Injection (Drug); 0.9% Saline (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Nanjing Medical University Official(s) and/or principal investigator(s):
XiaoFeng Shen, MD, Study Director, Affiliation: Nanjing Medical University
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.
Clinical Details
Official title: Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Visual analog scale (VAS) of pain
Secondary outcome: First requirement of morphine;
Total morphine consumption;
VAS sedation;
VAS satisfaction;
Side effects;
Overall conditions of patients;
Eligibility
Minimum age: 19 Years.
Maximum age: 64 Years.
Gender(s): Female.
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.
Locations and Contacts
Nanjing Maternal and Child Care Hospital, Nanjing, Jiangsu 210004, China
Additional Information
Starting date: August 2007
Ending date: November 2007
Last updated: April 17, 2008
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