Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

Seoul National University

Status: Completed

Conditions: Ibuprofen; Hyperalgesia; Pain, Postoperative; Remifentanil

Treatments: Drug: high dose remifentanil; Drug: Ibuprofen; Drug: low dose remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02243254

ibuprofen_hyperalgesia

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 4 patient groups, including a placebo group

high dose remifentanil without ibuprofen

Placebo Comparator group

Description:

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

Treatment:

Drug: high dose remifentanil

low dose remifentanil without ibuprofen

Placebo Comparator group

Description:

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

Treatment:

Drug: low dose remifentanil

high dose remifentanil with ibuprofen

Active Comparator group

Description:

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

Treatment:

Drug: high dose remifentanil

Drug: Ibuprofen

low dose remifentanil with ibuprofen

Active Comparator group

Description:

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

Treatment:

Drug: Ibuprofen

Drug: low dose remifentanil