Overview

Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia

Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
BACKGROUND : There has been increasing interest on the use of nefopam in i.v. patient-controlled analgesia (PCA). OBJECTIVE : The aim of this study was to evaluate the opioid-sparing effect of nefopam, when administered via i.v. PCA with fentanyl, after laparotomy. The adverse events associated with its use were also evaluated, and specific considerations in its clinical use were reviewed. DESIGN : A randomized, controlled, single-centre, double-blinded study. SETTING : One Korean university hospital. PATIENTS : Seventy-one patients planned for elective open laparotomy INTERVENTIONS : Patients were assigned into SF (control) or NF group, who received IV PCA with fentanyl in normal saline (25 µg/ml), or a solution with 120 mg of nefopam included (fentanyl 25 µg/ml and nefopam 1.2 mg/ml), respectively. MAIN OUTCOME MEASURES : The pain intensity during the 24 h study period and patient satisfaction at the end of the study were evaluated. Adverse events were observed.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Seoul National University Hospital
Collaborator:
Pharmbio Korea Co., Ltd.
Treatments:
Fentanyl
Nefopam
Pharmaceutical Solutions