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Trial record 29 of 663 for:    OXYCODONE

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

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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

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.

Condition or disease Intervention/treatment Phase
Surgery Drug: Extended-release oxycodone Drug: Extended- release Oxycodone Drug: ketoprofen Drug: dipirone Drug: dexametasone Drug: Morphine IV (rescue) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
Study Start Date : March 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Extended-release oxycodone 10mgr
Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
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)

Experimental: Extended-release oxycodone 20 mgr
Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
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)




Primary Outcome Measures :
  1. Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Percents of patients with adverse events because of treatment [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02238340


Locations
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Venezuela
Servicio de Aestesiologia.Hospital "Dr Luis Ortega"
Porlamar, Nueva Esparta, Venezuela, 6301
Sponsors and Collaborators
Hospital Central Dr. Luis Ortega
Investigators
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Principal Investigator: Beatriz S Arismendi Gomez, MD Sociedad Venezolana de Anestesiologia

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Responsible Party: Beatriz Arismendi Gómez, Medico Anestesiologo, Hospital Central Dr. Luis Ortega
ClinicalTrials.gov Identifier: NCT02238340     History of Changes
Other Study ID Numbers: Oxycodone
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014
Keywords provided by Beatriz Arismendi Gómez, Hospital Central Dr. Luis Ortega:
Postoperatory pain
Oxycodone
Additional relevant MeSH terms:
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Oxycodone
Ketoprofen
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action