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Trial record 29 of 672 for:    OXYCODONE

Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02238340
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Beatriz Arismendi Gómez, Hospital Central Dr. Luis Ortega

Tracking Information
First Submitted Date  ICMJE September 2, 2014
First Posted Date  ICMJE September 12, 2014
Last Update Posted Date September 12, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2014)
Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2014)
Percents of patients with adverse events because of treatment [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
Official Title  ICMJE Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
Brief Summary Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the patient, including significant cardiovascular and respiratory complications. Apart from the human suffering that is undeniable pain. Schemes oral analgesia with opioids for the treatment of DAPO, have shown to be as or more effective than intravenous or epidural regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20) undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at rest and effort, requirement for rescue intravenous morphine and incidence of side effects to the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and patient satisfaction.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Surgery
Intervention  ICMJE
  • Drug: Extended-release oxycodone
    10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery
  • Drug: Extended- release Oxycodone
  • Drug: ketoprofen
    Other Name: Both groups received ketoprofen
  • Drug: dipirone
    Other Name: Both groups received dipirone
  • Drug: dexametasone
    Other Name: Both groups received dexametasone
  • Drug: Morphine IV (rescue)
    Other Name: Both groups received Morphine IV (rescue)
Study Arms  ICMJE
  • Experimental: Extended-release oxycodone 10mgr
    Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
    Interventions:
    • Drug: Extended-release oxycodone
    • Drug: Extended- release Oxycodone
    • Drug: ketoprofen
    • Drug: dipirone
    • Drug: dexametasone
    • Drug: Morphine IV (rescue)
  • Experimental: Extended-release oxycodone 20 mgr
    Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
    Interventions:
    • Drug: Extended-release oxycodone
    • Drug: Extended- release Oxycodone
    • Drug: ketoprofen
    • Drug: dipirone
    • Drug: dexametasone
    • Drug: Morphine IV (rescue)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2014)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I and II patients between 18 and 60 years old, both sexes, undergoing elective orthopedic surgery.

Exclusion Criteria:

  • Use of psychotropic medication or illicit drug use
  • Pregnancy
  • Liver disease
  • Opioid use
  • History of postoperative nausea and vomiting
  • Ileus
  • Allergy or intolerance to any of the study drugs
  • Physical or mental inability to use the pain scale, or any surgical complications.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02238340
Other Study ID Numbers  ICMJE Oxycodone
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beatriz Arismendi Gómez, Hospital Central Dr. Luis Ortega
Study Sponsor  ICMJE Hospital Central Dr. Luis Ortega
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Beatriz S Arismendi Gomez, MD Sociedad Venezolana de Anestesiologia
PRS Account Hospital Central Dr. Luis Ortega
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP