title: Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study.
abstract: BACKGROUND
  Because nefopam's morphine-sparing is debated when combined with paracetamol, this study aimed to assess pain relief by IV nefopam in combination with paracetamol after major abdominal surgery.
  
  
  METHODS
  This was a prospective, double-blinded randomized controlled study including patients (ASA I-III, >18 years) scheduled for elective colectomy surgery by laparotomy. Patients were randomized into the nefopam group (N.=37, continuous IV 120 mg nefopam) or control group (N.=32, placebo, same infusion) for 48 hours after surgery (both groups: IV paracetamol 1 g/6 h + IV PCA morphine rescue). The primary endpoint was the total morphine consumption from the potential titration in the postoperative care unit to 48 hours (20% reduction in nefopam group). The secondary endpoints were adverse events and clinical outcomes.
  
  
  RESULTS
  Both groups were similar for demographic characteristic, surgery, and anesthesia (including IV sufentanil 20 [20-25] µg for nefopam vs. 22.5 [20-25] µg for the control, P=0.6). Time in PACU and hospital stay were not statistically different. The number of patients requiring titration in PACU and the amount of IV morphine titration were similar. As the main endpoint, morphine consumption over the study period was similar between nefopam and the control group (respectively, 53±37 and 54±34 mg, P=0.86). No difference was observed for pain relief satisfaction between groups or total adverse events like PONV, ileus, desaturation, or confusion (nefopam 14±38 vs. control group 11±34, P=0.77).
  
  
  CONCLUSIONS
  This prospective randomized study suggested that nefopam in combination with paracetamol has no benefit after open abdominal surgery.
authors.affiliation: Department of Anesthesiology and Pain Management, Caremeau University Hospital, Nîmes, France - philippe.cuvillon@chu-nimes.fr.|Montpellier 1 University, Montpellier, France - philippe.cuvillon@chu-nimes.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Cuvillon
authors.affiliation: Department of Anesthesiology and Pain Management, Caremeau University Hospital, Nîmes, France.|Montpellier 1 University, Montpellier, France.
authors.forename: Lana
authors.initials: L
authors.lastname: Zoric
authors.affiliation: Department of Biostatistics, Epidemiology, Public Health, and Medical Information (BESPIM), Nîmes University Hospital, Nîmes, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Demattei
authors.affiliation: Department of Biostatistics, Epidemiology, Public Health, and Medical Information (BESPIM), Nîmes University Hospital, Nîmes, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Alonso
authors.affiliation: Department of Anesthesiology and Pain Management, Caremeau University Hospital, Nîmes, France.|Montpellier 1 University, Montpellier, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Casano
authors.affiliation: Department of Anesthesiology and Pain Management, Caremeau University Hospital, Nîmes, France.|Montpellier 1 University, Montpellier, France.
authors.forename: Joel
authors.initials: J
authors.lastname: L'hermite
authors.affiliation: Department of Anesthesiology and Pain Management, Caremeau University Hospital, Nîmes, France.|Montpellier 1 University, Montpellier, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Ripart
authors.affiliation: Department of Anesthesiology and Pain Management, Caremeau University Hospital, Nîmes, France.|Montpellier 1 University, Montpellier, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Lefrant
authors.affiliation: Department of Anesthesiology and Pain Management, Caremeau University Hospital, Nîmes, France.|Montpellier 1 University, Montpellier, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Muller
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000082:Acetaminophen / Q000008:administration & dosage*; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D000701:Analgesics, Opioid / Q000008:administration & dosage; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage; D009340:Nefopam / Q000008:administration & dosage*; D010149:Postoperative Pain / Q000188:drug therapy*; D011446:Prospective Studies
chemical_list: D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D004338:Drug Combinations; D000082:Acetaminophen; D009340:Nefopam; D009020:Morphine