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Completed

NCT Number: NCT00564603

Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After 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.

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Key information

Conditions

Postoperative Pain Abdominal Surgeries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Patient-Controlled Analgesia Post Operative Analgesia Postoperative Complications Signs and Symptoms

Age range

19 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone sodium phosphate injection

Drug

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

0.9% saline

Other

Saline, in same volume of 2mL

Primary outcomes

  1. Visual analog scale (VAS) of pain

    Time frame: 0-48h after surgeries

Secondary outcomes

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

    Time frame: 0-48h after surgeries

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy

Acronym: DTMPCA

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Nov 28, 2007
Registry last updated
Apr 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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