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

This study has been completed.
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00209495
First received: September 13, 2005
Last updated: February 28, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
 Drug: Pregabalin; Dexamethasone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Score (VAS) at rest and at mobilisation. [ Time Frame: 0 - 24h ] [ Designated as safety issue: No ]
  • Postoperative nausea and vomiting. [ Time Frame: 0 - 24h ] [ Designated as safety issue: No ]
  • Sedation. [ Time Frame: 0 - 24h ] [ Designated as safety issue: No ]
  • Dizziness. [ Time Frame: 0 - 24h ] [ Designated as safety issue: No ]
  • All measurements are taken at 2, 4 and 24 h postoperatively. [ Time Frame: 0 - 24h ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: June 2005
Study Completion Date: February 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: Pregabalin; Dexamethasone
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Experimental: B
Pregabalin
 Drug: Pregabalin; Dexamethasone
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Experimental: C
Pregabalin + dexamethasone
 Drug: Pregabalin; Dexamethasone
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Detailed Description:

Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209495

Locations
Denmark
Operations og Anæstesiologisk afd. Y, KAS Glostrup
Glostrup, Copenhagen, Denmark, 2600
Herning Centralsygehus
Herning, Denmark, 7400
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Ole Mathiesen, MD Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00209495     History of Changes
Other Study ID Numbers: SM1-04
Study First Received: September 13, 2005
Last Updated: February 28, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Glostrup University Hospital, Copenhagen:
Abdominal hysterectomy
Pregabalin
Dexamethasone
Multimodal postoperative analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Pregabalin
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Analgesics, Opioid
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2013