The Effect of Gabapentin, Ketamine and Dexamethasone on P... | NCT00236223

Studies
The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery

NCT00236223

Sponsor

Glostrup University Hospital, Copenhagen

Status

Terminated

Last Update Posted

May 15, 2008Estimated

Enrollment

48Actual

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Gabapentin + dexamethasone + ketamine
Placebo

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

May 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Structural changes that stopped the type of operations used in the study

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Apr 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Oct 7, 2005

First Submission Date that Met QC Criteria

Oct 7, 2005

First Posted Date

Oct 12, 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

May 14, 2008

Last Update Posted Date

May 15, 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

Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are 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

The effect on postoperative pain of the combination of preoperative gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15mg/kg versus placebo is investigated on patients having a hip alloplastic operation.

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

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Gabapentin + dexamethasone + ketamine
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin + dexamethasone + ketamine	Drug	Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a 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
Dizziness

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for primary total hip replacement,
Between 55 and 85 years of age,
ASA 1-3 and BMI between 18 and 35.

Exclusion Criteria:

Patients who are:

Unable to cooperate
Does not speak Danish
Has allergy for drugs used in the trial
Drug or alcohol abuse
Epilepsy
Medically treated diabetes
Known kidney disease
Daily use of analgetics
Apart from NSAID
Paracetamol or COX2 inhibitors
Are treated with a antidepressive.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 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		2600	Denmark
Anæstesiafdelingen, Herning Centralsygehus

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
D000077206	Gabapentin
D003907	Dexamethasone
D007649	Ketamine

Ancestor Terms

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

Browse Leaves

Not provided

Browse Branches

Not provided