NCT02479165

Brief Summary

The aim of this randomized controlled study is to shed light on the analgesic properties and side-effect profile of an opiod-based regimen as opposed to an Ibuprofene based regimen.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started May 2009

Longer than P75 for phase_4 postoperative-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

March 31, 2015

Last Update Submit

June 19, 2015

Conditions

Postoperative PainRenal InsufficiencyMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Pain score - Visual Analouge Scale

    Visual analouge scale from 0-10, recorded at noon every day. Given as average/minimum/maximum previous 24h by patient. Until discharge, average 5th postoperative day.

    5 days

Secondary Outcomes (12)

  • Bowel movement, hours until movement

    5 days

  • Nausea, Hours

    5 days

  • Vomiting, events pr. 24 hours

    5 days.

  • Hallucination, events pr. 24 hours

    5 days

  • Confusion

    5 days

  • +7 more secondary outcomes

Study Arms (2)

Opioid group

ACTIVE COMPARATOR

If randomized to the opiod group, the patient was given the following regimen for 1 week, upon return from the intensive care unit, after surgery. Tbl. Oxycodone (slow-release) 10mg, Twice daily for 1 week Tbl. Paracetamol 1000mg, Four times daily for 1 week Tbl.oxycodone 5mg Max 4 times daily, as needed, until discharge. Inj, oxycodone 2.5 mg, Max 4 times daily, as needed, until discharge Tbl. Magnesia 1g, Twice daily, for 1 week Sol. Sodiumpicosulfate 7.5mg/ml 10 drops daily, for 1 week

Drug: Oxycodone

Ibuprofene group

ACTIVE COMPARATOR

If randomized to the ibuprofen group, the patient was given the following regimen for 1 week, upon return from the intensive care unit, after surgery. Tbl. Ibuprofen (slow-release) 800mg, Twice daily, for 1 week Tbl. Paracetamol 1000mg, Four times daily, for 1 week Tbl.oxycodone 5mg Max 4 times daily, as needed. Until discharge. Inj, oxycodone 2.5 mg Max 4 times daily, as needed. Until discharge. Tbl. Lanzoprazole 40 mg, Once daily, for 1 week Tbl. Magnesia 1g, Twice daily, for 1 week Sol. Sodiumpicosulfate 7.5mg/ml, 10 drops daily, for 1 week

Drug: Ibuprofene

Interventions

IbuprofeneDRUG

The Ibuprofene group is given an ibuprofen based analgesic regimen, to be compared with the standard opiod based regimen.

Also known as: Ipren, Advil, Motrin, Nurofen
Ibuprofene group
OxycodoneDRUG

The opioid group is given an oxycodone based analgesic regimen.

Also known as: Oxycontin
Opioid group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac surgery through median sternotomy
  • Written consent
  • Age over 18 years

You may not qualify if:

  • Other forms of sternotomy (i.e. re-sternotomy or partial sternotomy)
  • Preoperative creatinine over 110 µmol/L
  • Preoperative use of opioids or NSAIDs in analgesic doses (aspirin in antithrombotic doses was accepted)
  • Allergy to NSAIDs or opioids, and other contraindications to the used drugs
  • Staying more than one night at the intensive care unit
  • Unacceptable side effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, PostoperativeRenal InsufficiencyMyocardial Infarction

Interventions

IbuprofenOxycodone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosis

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Martin A Norgaard, DMsc

    Dep. of cardiothoracic surgery, Aalborg university hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMsc

Study Record Dates

First Submitted

March 31, 2015

First Posted

June 24, 2015

Study Start

May 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2013

Last Updated

June 24, 2015

Record last verified: 2015-06