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Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01966172
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):
Sulman Rafiq, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE September 30, 2013
First Posted Date  ICMJE October 21, 2013
Last Update Posted Date October 21, 2013
Study Start Date  ICMJE March 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2013)
Evaluation of analgesic effect by 11-NRS scale [ Time Frame: 4th postoperative day ]
assessement of analgesic effect for the first 4 days after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2013)
  • Additional analgesic consumption [ Time Frame: 4th postoperative day ]
  • Hospital stay in days. [ Time Frame: days until discharge ]
  • Evaluation of side-effects by daily questionnaire [ Time Frame: 4th postoperative day ]
  • Cardiac complications [ Time Frame: 30th postoperative day ]
    i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation.
  • Other complications [ Time Frame: 30th postoperative day ]
    i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications.
  • 30 day Mortality [ Time Frame: 30th postoperative day ]
    Death from all causes.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery
Official Title  ICMJE Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Analgesia
  • Postoperative Pain
Intervention  ICMJE
  • Drug: Ibuprofen
    oral ibuprofen 400mg 4 times daily
    Other Name: non-selective Non-steroid antiinflammatory drug (NSAID)
  • Drug: Gabapentin
    Oral Gabapentin 300mg twice daily
  • Drug: Morphine
    10 mg morphine orally 4 times daily
    Other Name: An opiod
  • Drug: Paracetamol
    oral paracetamol 1000mg four times daily
Study Arms  ICMJE
  • Experimental: Multimodal
    oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily
    Interventions:
    • Drug: Ibuprofen
    • Drug: Gabapentin
    • Drug: Paracetamol
  • Active Comparator: Morphine
    oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily
    Interventions:
    • Drug: Morphine
    • Drug: Paracetamol
Publications * Rafiq S, Steinbrüchel 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2013)
180
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • In addition intensive care unit (ICU) stay for more than 24 hours was used as a pre-defined post randomization exclusion criteria, because prolonged ICU stay and ventilator treatment would interfere with study analgesic protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01966172
Other Study ID Numbers  ICMJE Smerte1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sulman Rafiq, Rigshospitalet, Denmark
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Skov Olsen, MD,PhD,DMSc Rigshospitalet, Denmark
Study Chair: Sulman Rafiq, MD Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP