Skip to main content
OpenTrials
Completed

NCT Number: NCT02732262

Optimal Dose of i.v Oxycodone for Postoperative Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Acute Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone, 1.00 mg dose

Drug

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

Other names: OxyNorm

Oxycodone, 0.03 mg/kg dose

Drug

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

Other names: OxyNorm

Oxycodone, 0.02 mg/kg dose

Drug

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

Other names: OxyNorm

Primary outcomes

  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 outcomes

  1. Side effects

    Time frame: 24 hr after surgery

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

Other outcomes

  1. Sedation

    Time frame: 24 hr after surgery

    sedation with Ramsay sedation score (1-6) at 24 hr after surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 8, 2016
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.