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

NCT00564603 | Completed Phase 4 DMC

• 2 other identifiers: NMU-2579-5FW06NMUZ028
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Post Operative Analgesia; Patient-Controlled Analgesia; Abdominal Surgeries

Keywords

Glucocorticoid; Opioids; Balanced analgesia

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS) of pain

  0-48h after surgeries

Secondary Outcomes (1)

• First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;

  0-48h after surgeries

Study Arms (2)

1

PLACEBO COMPARATOR

Saline with same volume added to tramadol infusion combined with morphine PCA.

Other: 0.9% Saline

2

ACTIVE COMPARATOR

Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.

Drug: Dexamethasone Sodium Phosphate Injection

Interventions

Dexamethasone Sodium Phosphate Injection DRUG

Dexamethasone, 10mg, continuously infused up to 48h after surgeries.

2

0.9% Saline OTHER

Saline, in same volume of 2mL

1

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I-II
• Chinese
• Uterus myoma

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead
• HRSA/Maternal and Child Health Bureau: collaborator

Study Sites (1)

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

dexamethasone 21-phosphate; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• XiaoFeng Shen, MD

  Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 28, 2007
• Study Start: August 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 21, 2008

Record last verified: 2008-04

Locations

CN (1)