Oral Oxycodone After Major Cardiac Surgery

Heart; Dysfunction Postoperative, Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816581
• Other study ID #: 1043/2010
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2013
• Last updated: March 25, 2014
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention

Drug:
• Targin

• Oxynorm

• Morphine

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total opioid dosage in terms of so-called morphine equivalents	total administrated opioid dosage during 3 days after surgery	3 days	Yes
Secondary	VAS pain score	Pain Scores on the Visual Analog Scale (0-100)	3 days	Yes
Secondary	level of sedation	Level of Sedation using the Ramsey Sedation Score.	3 days	Yes
Secondary	rate of spontaneous breathing	spontaneous breathing rate per minute	3 days	Yes
Secondary	possible side effects	open documentation of any side effects like dizziness, vomiting, allergic reaction	3 days	Yes
Secondary	in hospital stay		1 month	No
Secondary	ICU stay		1 month	No