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Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients

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ClinicalTrials.gov Identifier: NCT00209495
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 29, 2008
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen

September 13, 2005
September 21, 2005
February 29, 2008
June 2005
November 2007   (Final data collection date for primary outcome measure)
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 ]
The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)
Complete list of historical versions of study NCT00209495 on ClinicalTrials.gov Archive Site
  • Pain Score (VAS) at rest and at mobilisation. [ Time Frame: 0 - 24h ]
  • Postoperative nausea and vomiting. [ Time Frame: 0 - 24h ]
  • Sedation. [ Time Frame: 0 - 24h ]
  • Dizziness. [ Time Frame: 0 - 24h ]
  • All measurements are taken at 2, 4 and 24 h postoperatively. [ Time Frame: 0 - 24h ]
  • 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.
Not Provided
Not Provided
 
Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients
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.
Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Pain, Postoperative
Drug: Pregabalin; Dexamethasone
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
  • Placebo Comparator: A
    Intervention: Drug: Pregabalin; Dexamethasone
  • Experimental: B
    Pregabalin
    Intervention: Drug: Pregabalin; Dexamethasone
  • Experimental: C
    Pregabalin + dexamethasone
    Intervention: Drug: Pregabalin; Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
120
February 2008
November 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00209495
SM1-04
Yes
Not Provided
Not Provided
Not Provided
Glostrup University Hospital, Copenhagen
Not Provided
Principal Investigator: Ole Mathiesen, MD Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
Glostrup University Hospital, Copenhagen
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP