- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00209495
Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients
February 28, 2008 updated by: Glostrup University Hospital, Copenhagen
Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Abdominal Hysterectomy.
Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine.
Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed.
We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated.
Primary outcome is 24 hours morphine usage.
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Herning, Denmark, 7400
- Herning Centralsygehus
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Copenhagen
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Glostrup, Copenhagen, Denmark, 2600
- Operations og Anæstesiologisk afd. Y, KAS Glostrup
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2
- BMI between 18-32.
Exclusion Criteria:
Patients who:
- Are unable to cooperate
- Has cancer ovarian
- Does not speak Danish
- Has allergy for drugs used in the trial
- Has drug and medicine abuse
- Epilepsy
- Diabetes treated with medicine
- Chronic pain condition
- Daily use of antacids or analgesic
- Known kidney disease
- Use of antidepressive
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: A
|
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
|
Experimental: B
Pregabalin
|
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
|
Experimental: C
Pregabalin + dexamethasone
|
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)
Time Frame: 0 - 24h
|
0 - 24h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain Score (VAS) at rest and at mobilisation.
Time Frame: 0 - 24h
|
0 - 24h
|
Postoperative nausea and vomiting.
Time Frame: 0 - 24h
|
0 - 24h
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Sedation.
Time Frame: 0 - 24h
|
0 - 24h
|
Dizziness.
Time Frame: 0 - 24h
|
0 - 24h
|
All measurements are taken at 2, 4 and 24 h postoperatively.
Time Frame: 0 - 24h
|
0 - 24h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ole Mathiesen, MD, Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
February 29, 2008
Last Update Submitted That Met QC Criteria
February 28, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Dexamethasone
- Pregabalin
Other Study ID Numbers
- SM1-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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