Optimal Dose of i.v Oxycodone for Postoperative Pain

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Oxycodone, 0.02 mg/kg dose; Drug: Oxycodone, 1.00 mg dose; Drug: Oxycodone, 0.03 mg/kg dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02732262

JHSeo-Oxynorm

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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134 participants in 3 patient groups

Oxycodone, 1.00 mg dose

Experimental group

Description:

Regimen of intravenous patientcontrolled analgesia consists of bolus dose of oxycodone 1.00 mg with lock out time of 10 min without basal infusion.

Treatment:

Drug: Oxycodone, 1.00 mg dose

Oxycodone, 0.03 mg/kg dose

Experimental group

Description:

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.

Treatment:

Drug: Oxycodone, 0.03 mg/kg dose

Oxycodone, 0.02 mg/kg dose

Experimental group

Description:

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.

Treatment:

Drug: Oxycodone, 0.02 mg/kg dose