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Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

NCT ID: NCT01966172

Last Updated: 2013-10-21

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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-12-31

Brief Summary

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To test if multimodal analgesia with different analgesic medication offer better pain relief, lesser side effects and is safe compared to conventionel opiod analgesia after cardiac surgery.

Detailed Description

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Conditions

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Analgesia Postoperative Pain

Keywords

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NSAID, gabapentin, multimodal, morphine, dexamethasone, cardiac surgery, postoperative pain, analgesia.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Multimodal

oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

oral ibuprofen 400mg 4 times daily

Gabapentin

Intervention Type DRUG

Oral Gabapentin 300mg twice daily

Paracetamol

Intervention Type DRUG

oral paracetamol 1000mg four times daily

Morphine

oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

10 mg morphine orally 4 times daily

Paracetamol

Intervention Type DRUG

oral paracetamol 1000mg four times daily

Interventions

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Ibuprofen

oral ibuprofen 400mg 4 times daily

Intervention Type DRUG

Gabapentin

Oral Gabapentin 300mg twice daily

Intervention Type DRUG

Morphine

10 mg morphine orally 4 times daily

Intervention Type DRUG

Paracetamol

oral paracetamol 1000mg four times daily

Intervention Type DRUG

Other Intervention Names

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non-selective Non-steroid antiinflammatory drug (NSAID) An opiod

Eligibility Criteria

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Inclusion Criteria

* age\>18
* any cardiac procedure with sternotomy
* able to give informed consent

Exclusion Criteria

* cardiac surgery without sternotomy
* peripheral neuropathy
* neurological disease
* psychiatric illness
* history of GI bleeding
* chronic pain (i.e. back pain, cancer, arthritis)
* serum creatinine \>150 μmol/l
* hepatic disease with elevated liver enzymes (SGPT and SGOT elevated to 1.5 times maximum normal value)
* allergic to study medication
* alcohol abuse
* abuse of narcotics or medication
* pregnancy
* participation in other clinical trials
* insufficient language skills
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Sulman Rafiq

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Skov Olsen, MD,PhD,DMSc

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Sulman Rafiq, MD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Rafiq S, Steinbruchel DA, Wanscher MJ, Andersen LW, Navne A, Lilleoer NB, Olsen PS. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial. J Cardiothorac Surg. 2014 Mar 20;9:52. doi: 10.1186/1749-8090-9-52.

Reference Type DERIVED
PMID: 24650125 (View on PubMed)

Other Identifiers

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Smerte1

Identifier Type: -

Identifier Source: org_study_id