Safety and Tolerability of Controlled-release Oxycodone on Postoperative Pain in Oncologic Head and Neck Surgery

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis of this study is that controlled release oxycodone can be safe and well tolerated for the control of postoperative pain in surgery for head and neck cancer. The primary objective is to study the safety and the incidence and severity of adverse effects, and the secondary objective is to evaluate the analgesic efficacy and identify the frequency of use of rescue medication and the prescribing physician's opinion about the quality of postoperative analgesia with oxycodone controlled release in oncologic surgery of the head and neck.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancer, Brazil
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

• patients on postoperative head and neck oncologic surgery

• 2 and 3 American Society of Anesthesiologists physical status

• moderate to severe postoperative pain

• elective surgery

• able to swallow tablets whole (not chewed, broken or crushed) in the immediate postoperative period after recovery of cognitive functions.

Exclusion Criteria:

• pregnant or breastfeeding

• allergic to oxycodone and other opioids

• gastrectomized or colostomized

• asthmatics with severe organ dysfunction

• history or suspected paralytic ileus

• history psychiatric disorders

• severe respiratory depression

• patients who are receiving opioid analgesics in baseline

• history of abuse of alcohol and illicit drugs

• plasma glutamic oxaloacetic transaminase above 48 U / l (men) and 40 U / I (women) and / or glutamic pyruvic transaminase above 53 U / l (men) and 40 U / I (women)

• plasma creatinine above 1.7 mg / dl and / or urea above 65 mg / dl

• emergency surgery