Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients.
Information source: Glostrup University Hospital,Copenhagen
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Pregabalin; Dexamethasone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Glostrup University Hospital,Copenhagen Official(s) and/or principal investigator(s):
Ole Mathiesen, MD, Principal Investigator, Affiliation: Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
Overall contact:
Ole Mathiesen, MD, Phone: 0045 43 23 25 14, Email: olem@glostruphosp.kbhamt.dk
Summary
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.
Clinical Details
Official title: 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.
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)
Secondary outcome: Pain Score (VAS) at rest and at mobilisation.Postoperative nausea and vomiting. Sedation. Dizziness. All measurements are taken at 2, 4 and 24 h postoperatively.
Detailed description:
Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin +
dexamethasone is investigated. Primary outcome is 24 hours morphine usage.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Ole Mathiesen, MD, Phone: 0045 43 23 25 14, Email: olem@glostruphosp.kbhamt.dk
Herning Centralsygehus, Herning 7400, Denmark; Recruiting
Gerd Dierking, MD, Phone: 00 45 99 27 27 27, Email: hecgd@ringamt.dk
Gerd Dierking, MD, Principal Investigator
Operations og Anæstesiologisk afd. Y, KAS Glostrup, Glostrup, Copenhagen 2600, Denmark; Recruiting
Ole Mathiesen, MD, Phone: 0045 43 23 25 14, Email: olem@glostruphosp.kbhamt.dk
Ole Mathiesen, MD, Principal Investigator
Additional Information
Starting date: June 2005
Ending date: December 2007
Last updated: November 13, 2007
|
