Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients - Full Text View

Sponsored by:	Glostrup University Hospital,Copenhagen
Information provided by:	Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier:	NCT00209495

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 IV

MedlinePlus related topics: Dizziness and Vertigo Hysterectomy Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Pregabalin Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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.

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
A: Placebo Comparator	Drug: Pregabalin; Dexamethasone Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
B: Experimental Pregabalin	Drug: Pregabalin; Dexamethasone Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
C: Experimental 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
Herning Centralsygehus
Herning, Denmark, 7400
Denmark, Copenhagen
Operations og Anæstesiologisk afd. Y, KAS Glostrup
Glostrup, Copenhagen, Denmark, 2600

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

Study ID Numbers:	SM1-04
Study First Received:	September 13, 2005
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00209495
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

Study placed in the following topic categories:

Dexamethasone
Signs and Symptoms
Postoperative Complications
Pregabalin

Pain
Acetaminophen
Dexamethasone acetate
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Hormones
Glucocorticoids
Pharmacologic Actions

Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Autonomic Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009