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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00564603

Acronym

DTMPCA

Enrollment

300

Registered

2007-11-28

Start date

2007-08-31

Completion date

2007-11-30

Last updated

2008-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Glucocorticoid, Opioids, Balanced analgesia

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.

Interventions

DRUGDexamethasone Sodium Phosphate Injection

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

OTHER0.9% Saline

Saline, in same volume of 2mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 64 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Visual analog scale (VAS) of pain	0-48h after surgeries

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026