Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Pharmbio Korea Co., Ltd.
• Treatments: Fentanyl; Nefopam; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• those planned for elective open laparotomy under general anesthesia, who were classified as ASA physical status I-II

Exclusion Criteria:

• the presence of renal and hepatic disease, high risk of urinary retention, seizure history, known allergy to any of the medications used, current history of psychiatric disorder, or those presently taking psychotropic medications or monoamine oxidase inhibitors.

• Patients who could not understand verbal rating scale (VRS) and 11-points numeric rating scale (NRS) pain scores, or did not sign on informed consent