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Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

Primary Purpose

Ibuprofen, Remifentanil, Hyperalgesia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
high dose remifentanil
Ibuprofen
low dose remifentanil
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ibuprofen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

high dose remifentanil without ibuprofen

low dose remifentanil without ibuprofen

high dose remifentanil with ibuprofen

low dose remifentanil with ibuprofen

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

cumulative morphine consumption
cumulative patient-controlled analgesia (PCA) morphine consumption

Secondary Outcome Measures

Pain score
visual analogue scale

Full Information

First Posted
September 15, 2014
Last Updated
November 16, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02243254
Brief Title
Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ibuprofen, Remifentanil, Hyperalgesia, Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high dose remifentanil without ibuprofen
Arm Type
Placebo Comparator
Arm Description
remifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision
Arm Title
low dose remifentanil without ibuprofen
Arm Type
Placebo Comparator
Arm Description
remifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision
Arm Title
high dose remifentanil with ibuprofen
Arm Type
Active Comparator
Arm Description
remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision
Arm Title
low dose remifentanil with ibuprofen
Arm Type
Active Comparator
Arm Description
remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision
Intervention Type
Drug
Intervention Name(s)
high dose remifentanil
Intervention Description
high dose remifentanil
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
intravenous ibuprofen
Intervention Type
Drug
Intervention Name(s)
low dose remifentanil
Intervention Description
low dose remifentanil
Primary Outcome Measure Information:
Title
cumulative morphine consumption
Description
cumulative patient-controlled analgesia (PCA) morphine consumption
Time Frame
postoperative 48 hours
Secondary Outcome Measure Information:
Title
Pain score
Description
visual analogue scale
Time Frame
postoperative 1, 3, 6,12, 24, 48 hours Pain score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

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