Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

November 16, 2015 updated by: Seoul National University Hospital
Postoperative hyperalgesia has been reported after intraoperative administration of small or high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the development of opioid-induced hyperalgesia. The aim of this study is to evaluate the preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients scheduled for elective pancreaticoduodenectomy

Exclusion Criteria:

  • Patients with chronic pain
  • Patients with psychiatric disease
  • Patients with nonsteroidal antiinflammatory drugs allergy
  • Patients with renail dysfunction
  • History of drug addiction
  • Pregnant patient
  • Inability to use a PCA device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: high dose remifentanil without ibuprofen
remifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision
Drug: high dose remifentanil
high dose remifentanil
Placebo Comparator: low dose remifentanil without ibuprofen
remifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision
Drug: low dose remifentanil
low dose remifentanil
Active Comparator: high dose remifentanil with ibuprofen
remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision
Drug: high dose remifentanil
high dose remifentanil
Drug: Ibuprofen
intravenous ibuprofen
Active Comparator: low dose remifentanil with ibuprofen
remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision
Drug: low dose remifentanil
low dose remifentanil
Drug: Ibuprofen
intravenous ibuprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative morphine consumption
Time Frame: postoperative 48 hours
cumulative patient-controlled analgesia (PCA) morphine consumption
postoperative 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: postoperative 1, 3, 6,12, 24, 48 hours Pain score
visual analogue scale
postoperative 1, 3, 6,12, 24, 48 hours Pain score

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ibuprofen_hyperalgesia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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