Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

Not Applicable

Completed

• Conditions: Ibuprofen; Remifentanil; Hyperalgesia; Pain, Postoperative
• Interventions: Drug: high dose remifentanil; Drug: low dose remifentanil; Drug: Ibuprofen

• Registration Number: NCT02243254
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-17
• Primary Completion: 2015-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose remifentanil without ibuprofen	high dose remifentanil	remifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision
low dose remifentanil without ibuprofen	low dose remifentanil	remifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision
high dose remifentanil with ibuprofen	high dose remifentanil	remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision
high dose remifentanil with ibuprofen	Ibuprofen	remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision
low dose remifentanil with ibuprofen	Ibuprofen	remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision
low dose remifentanil with ibuprofen	low dose remifentanil	remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision

Primary Outcome Measures

Name	Time	Method
cumulative morphine consumption	postoperative 48 hours	cumulative patient-controlled analgesia (PCA) morphine consumption

Secondary Outcome Measures

Name	Time	Method
Pain score	postoperative 1, 3, 6,12, 24, 48 hours Pain score	visual analogue scale

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of