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Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

NCT ID: NCT02243254

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Ibuprofen Remifentanil Hyperalgesia Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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high dose remifentanil without ibuprofen

remifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision

Group Type PLACEBO_COMPARATOR

high dose remifentanil

Intervention Type DRUG

high dose remifentanil

low dose remifentanil without ibuprofen

remifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision

Group Type PLACEBO_COMPARATOR

low dose remifentanil

Intervention Type DRUG

low dose remifentanil

high dose remifentanil with ibuprofen

remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision

Group Type ACTIVE_COMPARATOR

high dose remifentanil

Intervention Type DRUG

high dose remifentanil

Ibuprofen

Intervention Type DRUG

intravenous ibuprofen

low dose remifentanil with ibuprofen

remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

intravenous ibuprofen

low dose remifentanil

Intervention Type DRUG

low dose remifentanil

Interventions

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high dose remifentanil

high dose remifentanil

Intervention Type DRUG

Ibuprofen

intravenous ibuprofen

Intervention Type DRUG

low dose remifentanil

low dose remifentanil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ibuprofen_hyperalgesia

Identifier Type: -

Identifier Source: org_study_id