CompletedNot Applicable

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

Brazil83 participantsStarted 2010-10

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with nausea

Timeframe: 48 hours post dose

Trial details

NCT IDNCT01834898

SponsorInstituto Nacional de Cancer, Brazil

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2012-10

View on ClinicalTrials.gov More Postoperative Nausea trials