Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

Pain, Postoperative Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243254
• Other study ID #: ibuprofen_hyperalgesia
• Status: Completed
• Phase: N/A
• First received: September 15, 2014
• Last updated: November 16, 2015
• Start date: July 2014

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hyperalgesia
• Ibuprofen
• Pain, Postoperative
• Remifentanil

Intervention

Drug:
• high dose remifentanil
high dose remifentanil
• Ibuprofen
intravenous ibuprofen
• low dose remifentanil
low dose remifentanil

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative morphine consumption	cumulative patient-controlled analgesia (PCA) morphine consumption	postoperative 48 hours	Yes
Secondary	Pain score	visual analogue scale	postoperative 1, 3, 6,12, 24, 48 hours Pain score	Yes