Effect of Paracetamol,Pregabalin and Dexamethasone on Pai... | NCT00209495

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

NCT00209495

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Feb 29, 2008Estimated

Enrollment

130Actual

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Pregabalin; Dexamethasone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Nov 2007Actual

Completion Date

Feb 2008Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2008

Last Update Posted Date

Feb 29, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Placebo Comparator		Drug: Pregabalin; Dexamethasone
B	Experimental	Pregabalin	Drug: Pregabalin; Dexamethasone
C	Experimental	Pregabalin + dexamethasone	Drug: Pregabalin; Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin; Dexamethasone	Drug	Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg	A B C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)		0 - 24h

Secondary Outcomes

Measure	Description	Time Frame
Pain Score (VAS) at rest and at mobilisation.		0 - 24h
Postoperative nausea and vomiting.		0 - 24h
Sedation.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ole Mathiesen, MD	Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Operations og Anæstesiologisk afd. Y, KAS Glostrup		Glostrup Municipality	Copenhagen	2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069583	Pregabalin
D003907	Dexamethasone

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided