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

NCT01834898 | Completed DMC

• 2 other identifiers: INCA 10/2010IncaBrazil
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Nausea; Adverse Effects; Opioid Analgesic Adverse Reaction; Pain

Keywords

postoperative; analgesia; adverse effects; opioid; oxycodone

Outcome Measures

Primary Outcomes (1)

• Number of participants with nausea

  number of participants with nausea 48 hours after first dose of controlled-released oxycodone

  48 hours post dose

Secondary Outcomes (1)

• Pain intensity

  48 hours post dose

Other Outcomes (1)

• Degree of quality of postoperative analgesia

  At the seventh postoperative day

Study Arms (1)

Controlled-release oxycodone

Controlled-released oxycodone. First day postoperatively, 40 mg / day divided into 20 mg of 12 in 12 hours and in the second postoperative day, 20 mg / day divided into 10 mg of 12 in 12 hours

Drug: Controlled-release oxycodone

Interventions

Controlled-release oxycodone DRUG

Controlled-release oxycodone. First day postoperatively, 40 mg / day divided into 20 mg of 12 in 12 hours and in the second postoperative day, 20 mg / day divided into 10 mg of 12 in 12 hours

Also known as: Opioid, Postoperative analgesia, Postoperative pain

Controlled-release oxycodone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients on postoperative head and neck oncologic surgery which moderate to severe pain

You may qualify if:

• patients on postoperative head and neck oncologic surgery
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Instituto Nacional de Câncer José Alencar Gomes da Silva

Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain; Agnosia

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Neurologic Manifestations; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Ismar L Cavalcanti, MD PhD

  Instituto Nacional de Câncer Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 18, 2013
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 18, 2013

Record last verified: 2013-04

Locations

BR (1)