Ibuprofene
DrugThe Ibuprofene group is given an ibuprofen based analgesic regimen, to be compared with the standard opiod based regimen.
Other names: Ipren, Advil, Motrin, Nurofen
NCT Number: NCT02479165
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Background:
Postoperative pain following median sternotomy can represent a major postoperative problem as it can lead to reduced mobilization and shallow, restricted breathing and insufficient cough, which can lead to pulmonary complications.
However, pain management with opioids has frequent side-effects such as confusion, respiratory depression, sedation, nausea and obstipation/ paralytic ilieus. Non-steroid anti-inflammatory drugs (NSAIDs) can been used as opiod-sparing analgesics following cardiac surgery. However, this remains controversial, as NSAIDs has been linked to an increased risk of myocardial infarction, especially in patients with ischaemic heart disease, renal failure, gastrointestinal bleeding, and possibly impaired sternal healing.
The investigators wanted to investigate the analgesic properties of a opiod-based regimen with that of an ibuprofene-based, through randomization of patients to one of the two arms.
Intervention:
The participants were given analgesics in accordance to their randomization group upon return from the postoperative ICU stay.
The opioid regimen relied on a basic dose of slow-release oxycodone ("Oxycontin", Norpharma, Vedbaek, Denmark, 10mg two times daily) and paracetamol ("Panodil", GlaxoSmithKline, Copenhagen, Denmark, 1g four times daily). For "break-through pain" extra oxycodone was administered as injections or capsules (5mg pr. dose). Furthermore laxatives were co-administered to prevent obstipation.
In the ibuprofene regimen slow-release ibuprofen ("Brufen Retard", Abbott, Copenhagen, Denmark, 800mg two times daily) replaced oxycodone as the basic analgesic. In the ibuprofene regimen lansoprazol ("Lansoprazole", Actavis, Gentofte, Denmark, 30mg once daily) was co-administered to prevent development of gastric ulcers. These regimens were initiated the first postoperative day, when the patient was transferred from the ICU to the ward, and continued until the seventh postoperative day. Some patient
Outcome:
Please refer to the "outcome" chapter
Statistics:
Data are presented as number of patients, medians, and ranges. Patients are compared according to the ibuprofen or the oxycodone group, and statistics were done using "intention-to-treat"-design. Fischer's exact test, Mann-Whitney, and 95% confidence intervals were used as appropriate. Significance was defined as P-values below 0.05.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The postoperative exclusion criteria were:
The Ibuprofene group is given an ibuprofen based analgesic regimen, to be compared with the standard opiod based regimen.
Other names: Ipren, Advil, Motrin, Nurofen
The opioid group is given an oxycodone based analgesic regimen.
Other names: Oxycontin
Time frame: 5 days
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.
Time frame: 5 days
Time is noted of first bowel movement. Registration until discharge, average 5th postoperative day.
Time frame: 5 days
At noon, the total hours of nausea over the previous 24h is noted. Registration until discharge, average 5th postoperative day.
Time frame: 5 days.
Number of themes the patient has vomitted is noted. Registration until discharge, average 5th postoperative day.
Time frame: 5 days
At noon, it is recorded wether the patient has experienced hallucinations the previous 24h. Registration until discharge, average 5th postoperative day.
Time frame: 5 days
At noon, it is recorded wether the patient can name the given time, physical location own social security number. Registration until discharge, average 5th postoperative day.
Time frame: 5 days
At noon, it is recorded if the patient is given opiod antagonists (such as Naloxone) the previous 24h. Registration until discharge, average 5th postoperative day.
Time frame: 36 months
Se-creatinine recorded on the morning of postoperative day 1, 2 and 4 and as out-patient at followup.
Time frame: 36 months
Postoperative myocardial infarction according to ESC/ACC/AHA/WHF consensus-report. Registration until discharge, average 5th postoperative day, and as outpatients until followup.
Time frame: 36 months
All cause mortality until followup.
Time frame: 36 months
Sternal non-union from 1 month after surgery until followup.
Time frame: 36 months
Bleeding verified through gastroscopi or colonoscopi from operation until followup.
Time frame: 5 days
At noon, the degree of mobilization is noted on an scale from 0 (complete immobilization) - 4 (complete mobilization). Registration until discharge, average 5th postoperative day.
Aalborg University Hospital
Other
Pain Management After Cardiac Surgery - Opioids or NSAID? A Randomized Prospective Study
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