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Oral Oxycodone After Major Cardiac Surgery

Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain After Major Cardiac Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01816581
Enrollment
50
Registered
2013-03-22
Start date
2011-07-31
Completion date
2013-03-31
Last updated
2014-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Brief summary

Postoperative pain and analgesic treatment still remains a challenge in daily perioperative medicine. Skin incisions, intraoperative tissue retraction and -dissection, intravasal cannulations and drainages, sternotomy and pericardiotomy are the most important reasons for postoperative pain. Poorly controlled pain can contribute directly or indirectly to postoperative complications, such as myocardial ischemia, pulmonary dysfunction like hypoventilation, pneumonia and atelectasis, a delayed return of gastrointestinal function and decreased mobility. In addition, prolonged acute pain also results in chronic pain. Opioids are internationally recognized as the golden standard in the treatment of acute postoperative pain. On one side, the high potency of opioids in pain relief is clearly undisputed, but on the other hand, the administration of opioids is associated with nausea, vomiting, sedation and with the development of bowel dysfunction, which encompasses symptoms including bloating, abdominal spasm, cramps and constipation. Opioid-induced constipation is a frequently reported adverse effect and sometimes requires discontinuation of therapy, which results in analgesic under-treatment, severely impairing quality of life. However, there are many different regimes for the treatment of postoperative pain using opioids. Patient-controlled analgesia (PCA) using morphine is widely used, but requires trained staff and expensive equipment. Once patients are able to tolerate oral medications, the oral route is preferred postoperatively because it is more convenient, noninvasive and less expensive.

Interventions

DRUGTargin
DRUGMorphine

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Age from 18 to 90 years * ASA physical status 1-3 * Elective major cardiac surgery requiring sternotomy * Oral and written consent * Postoperative extubation within four hours after arrival at the ICU * Cognitive ability in the use of the PCA pump and the VAS

Exclusion criteria

* Chronic use of opioids in the last three months * Chronic use of tranquilizer or pain medications * Hypersensitivity against opioids * Use of monoamine oxidase inhibitors in the last two weeks before surgery * Alcohol or drug abuse * Renal dysfunction (GFR \< 30 or necessity of dialysis) * Liver Dysfunction defined as Child-Pugh-Score 7-15 * Ejection fraction (EF\< 40%) * Malabsorption syndrome * Neurologic or cognitive dysfunction * Pregnancy * Participation in another clinical trial * Severe respiratory depression with hypoxia and/or hypercapnia * Severe chronic obstructive pulmonary disease * Severe bronchial asthma * Non-opioid induced paralytic ileus * Risk of seizures

Design outcomes

Primary

MeasureTime frameDescription
total opioid dosage in terms of so-called morphine equivalents3 daystotal administrated opioid dosage during 3 days after surgery

Secondary

MeasureTime frameDescription
level of sedation3 daysLevel of Sedation using the Ramsey Sedation Score.
rate of spontaneous breathing3 daysspontaneous breathing rate per minute
VAS pain score3 daysPain Scores on the Visual Analog Scale (0-100)
in hospital stay1 month
ICU stay1 month
possible side effects3 daysopen documentation of any side effects like dizziness, vomiting, allergic reaction

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026