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Trial record 17 of 663 for:    OXYCODONE

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

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ClinicalTrials.gov Identifier: NCT01834898
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : April 18, 2013
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Cancer, Brazil

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.

Condition or disease Intervention/treatment
Postoperative Nausea Adverse Effects Opioid Analgesic Adverse Reaction Pain Drug: Controlled-release oxycodone

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 83 participants
Time Perspective: Prospective
Official Title: Phase 4 Study, Open, Observational, to Evaluate the Safety and Tolerability of Hydrochloride Controlled-release Oxycodone in Moderate and Severe Postoperative Pain in Oncologic Head and Neck Surgery.
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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
Other Names:
  • Opioid
  • Postoperative analgesia
  • Postoperative pain




Primary Outcome Measures :
  1. Number of participants with nausea [ Time Frame: 48 hours post dose ]
    number of participants with nausea 48 hours after first dose of controlled-released oxycodone


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 48 hours post dose ]
    pain intensity by numerical scale 48 hours after the first dose of controlled released oxycodone


Other Outcome Measures:
  1. Degree of quality of postoperative analgesia [ Time Frame: At the seventh postoperative day ]
    Investigator's opinion about treatment



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients on postoperative head and neck oncologic surgery which moderate to severe pain
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834898


Locations
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Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva
Rio de Janeiro, RJ, Brazil, 20230-130
Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
Investigators
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Principal Investigator: Ismar L Cavalcanti, MD PhD Instituto Nacional de Câncer Brazil

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Responsible Party: Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT01834898     History of Changes
Other Study ID Numbers: INCA 10/2010
IncaBrazil ( Other Identifier: Instituto Nacional de Câncer )
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: April 2013
Keywords provided by Instituto Nacional de Cancer, Brazil:
postoperative
analgesia
adverse effects
opioid
oxycodone
Additional relevant MeSH terms:
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Oxycodone
Pain, Postoperative
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Nausea
Signs and Symptoms, Digestive
Vomiting
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents