drugset / Trial / NCT02596269

Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia

NCT02596269

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-10
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Nefopam Small molecule 120 mg Intravenous

Indications

No indication recorded.