Optimal Dose of i.v Oxycodone for Postoperative Pain

Seoul National University Hospital134 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

134

Conditions

Pain

Interventions

Oxycodone, 1.00 mg doseDRUG

Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 1.00 mg.

Oxycodone, 0.03 mg/kg doseDRUG

Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.03 mg/kg.

Oxycodone, 0.02 mg/kg doseDRUG

Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.02 mg/kg.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Resting postoperative pain at 24hr

Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 010.

Time frame: 24 hr after surgery

Secondary Outcomes

Side effects

Secondary outcome includes any side effect at 24 hr after surgery.

Time frame: 24 hr after surgery

Data from ClinicalTrials.gov

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