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Oral Oxycodone After Major Cardiac Surgery

NCT01816581 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-03-26

No results posted yet for this study

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.

Conditions

  • Heart; Dysfunction Postoperative, Cardiac Surgery

Interventions

DRUG

Targin

DRUG

Oxynorm

DRUG

Morphine

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-05-31
Completion
2013-03-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01816581 on ClinicalTrials.gov