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

NCT ID: NCT00209495

Last Updated: 2008-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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

Conditions

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Pain, Postoperative

Keywords

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Abdominal hysterectomy Pregabalin Dexamethasone Multimodal postoperative analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type PLACEBO_COMPARATOR

Pregabalin; Dexamethasone

Intervention Type DRUG

Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

B

Pregabalin

Group Type EXPERIMENTAL

Pregabalin; Dexamethasone

Intervention Type DRUG

Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

C

Pregabalin + dexamethasone

Group Type EXPERIMENTAL

Pregabalin; Dexamethasone

Intervention Type DRUG

Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Interventions

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Pregabalin; Dexamethasone

Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

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Ole Mathiesen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark

Locations

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Operations og Anæstesiologisk afd. Y, KAS Glostrup

Glostrup Municipality, Copenhagen, Denmark

Site Status

Herning Centralsygehus

Herning, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SM1-04

Identifier Type: -

Identifier Source: org_study_id