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

NCT ID: NCT00564603

Last Updated: 2008-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-11-30

Brief Summary

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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

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Conditions

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Postoperative Pain Post Operative Analgesia Patient-Controlled Analgesia Abdominal Surgeries

Keywords

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Glucocorticoid Opioids Balanced analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type PLACEBO_COMPARATOR

0.9% Saline

Intervention Type OTHER

Saline, in same volume of 2mL

2

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

Group Type ACTIVE_COMPARATOR

Dexamethasone Sodium Phosphate Injection

Intervention Type DRUG

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

Interventions

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Dexamethasone Sodium Phosphate Injection

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

Intervention Type DRUG

0.9% Saline

Saline, in same volume of 2mL

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HRSA/Maternal and Child Health Bureau

FED

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Maternal and Child Health Hospital

Principal Investigators

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XiaoFeng Shen, MD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

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Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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06NMUZ028

Identifier Type: -

Identifier Source: secondary_id

NMU-2579-5FW

Identifier Type: -

Identifier Source: org_study_id