Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy

Phase 4

Completed

• Conditions: Postoperative Pain; Post Operative Analgesia; Patient-Controlled Analgesia; Abdominal Surgeries
• Interventions: Other: 0.9% Saline; Drug: Dexamethasone Sodium Phosphate Injection

• Registration Number: NCT00564603
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2007-11-26
• Study First Submitted QC: 2007-11-26
• Study First Posted: 2007-11-28
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-17
• Last Update Posted: 2008-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	0.9% Saline	Saline with same volume added to tramadol infusion combined with morphine PCA.
2	Dexamethasone Sodium Phosphate Injection	Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) of pain	0-48h after surgeries

Secondary Outcome Measures

Name	Time	Method
First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;	0-48h after surgeries

Trial Locations

Locations (1)

Nanjing Maternal and Child Care Hospital; 🇨🇳 Nanjing, Jiangsu, China