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Trial record 48 of 663 for:    OXYCODONE

Optimal Dose of i.v Oxycodone for Postoperative Pain

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ClinicalTrials.gov Identifier: NCT02732262
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jeong-Hwa Seo, Seoul National University Hospital

Brief Summary:

Postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control mainly in Europe.

The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean.


Condition or disease Intervention/treatment Phase
Pain Drug: Oxycodone, 1.00 mg dose Drug: Oxycodone, 0.03 mg/kg dose Drug: Oxycodone, 0.02 mg/kg dose Phase 3

Detailed Description:
Oxycodone is known to be effective in pain control and has less sedative effect than morphine does. It has been described that distribution of cytochrome P450, which is associated with metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone after major abdominal surgery has not been well defined in Korean. The purpose of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean based on pain score and side effects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
Actual Study Start Date : April 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxycodone, 1.00 mg dose
Regimen of intravenous patientcontrolled analgesia consists of bolus dose of oxycodone 1.00 mg with lock out time of 10 min without basal infusion.
Drug: Oxycodone, 1.00 mg dose
Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 1.00 mg.
Other Name: OxyNorm

Experimental: Oxycodone, 0.03 mg/kg dose
Regimen of intravenous patientcontrolled analgesia consists of bolus dose of oxycodone 0.03 mg/kg with lock out time of 10 min without basal infusion.
Drug: Oxycodone, 0.03 mg/kg dose
Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.03 mg/kg.
Other Name: OxyNorm

Experimental: Oxycodone, 0.02 mg/kg dose
Regimen of intravenous patientcontrolled analgesia consists of bolus dose of oxycodone 0.02 mg/kg with lock out time of 10 min without basal infusion.
Drug: Oxycodone, 0.02 mg/kg dose
Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.02 mg/kg.
Other Name: OxyNorm




Primary Outcome Measures :
  1. Resting postoperative pain at 24hr [ Time Frame: 24 hr after surgery ]
    Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 010.


Secondary Outcome Measures :
  1. Side effects [ Time Frame: 24 hr after surgery ]
    Secondary outcome includes any side effect at 24 hr after surgery.


Other Outcome Measures:
  1. Sedation [ Time Frame: 24 hr after surgery ]
    sedation with Ramsay sedation score (1-6) at 24 hr after surgery



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists class 1, 2
  • Expected surgical time between 2~ 6hours
  • Scheduled for laparoscopic colorectal surgery

Exclusion Criteria:

  • Severe dysfunction of liver, heart, kidney, or lung
  • Cannot understand numeric rating scale of pain
  • Known or suspected allergy to oxycodone
  • Previous history of postoperative nausea or vomiting
  • Medication of antidepressants
  • Postoperative longterm
  • ICU care or prolonged mechanical ventilatory support
  • Chronic pain
  • Drug abuser
  • Hypersensitivity reaction to aspirin or NSAIDs
  • Refuse to enroll

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): NCT02732262


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Jeong-Hwa Seo, associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02732262     History of Changes
Other Study ID Numbers: JHSeo-Oxynorm
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Keywords provided by Jeong-Hwa Seo, Seoul National University Hospital:
acute pain
postoperative
surgery
Additional relevant MeSH terms:
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Oxycodone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents