Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02243254
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ibuprofen; Remifentanil; Hyperalgesia; Pain, Postoperative	Drug: high dose remifentanil; Drug: Ibuprofen; Drug: low dose remifentanil	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Apr 1, 2015

Arms and Interventions

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: Ibuprofen; intravenous ibuprofen; Drug: low dose remifentanil; low dose remifentanil

Outcome Measures

Primary Outcome Measures

1. cumulative morphine consumption [postoperative 48 hours]

   cumulative patient-controlled analgesia (PCA) morphine consumption

Secondary Outcome Measures

1. Pain score [postoperative 1, 3, 6,12, 24, 48 hours Pain score]

   visual analogue scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02243254
• Other Study ID Numbers: ibuprofen_hyperalgesia
• First Posted: Sep 17, 2014
• Last Update Posted: Nov 18, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Hyperalgesia; Pain, Postoperative; Ibuprofen; Remifentanil

Study Results

No Results Posted as of Nov 18, 2015