title: Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial.
abstract: BACKGROUND
  Problems with intravenous patient-controlled analgesia (IV PCA) are well known, including invasive route of delivery and pump programming errors. The primary objective of this study was to evaluate patient satisfaction with a novel sublingual sufentanil PCA system (sufentanil sublingual tablet system 15 mcg with a 20-minute lockout interval; SSTS) to IV PCA morphine sulfate 1 mg with a 6-minute lockout interval (IV PCA MS) for the management of acute postoperative pain.
  
  
  METHODS
  This was a randomized, open-label, 48-hour non-inferiority study with optional extension to 72 hours at 26 U.S. sites enrolling patients scheduled for elective major open abdominal or orthopedic (hip or knee replacement) surgery. The primary outcome measure was the proportion of patients who responded "good" or "excellent" (collectively "success") at the 48-hour timepoint on the Patient Global Assessment of method of pain control (PGA48).
  
  
  RESULTS
  A total of 357 patients received study drug and 78.5% vs. 65.6% of patients achieved PGA48 "success" for SSTS vs. IV PCA MS, respectively, demonstrating non-inferiority (P < 0.001 using the one-side Z-test against the non-inferiority margin) as well as statistical superiority for treatment effect (P = 0.007). Patients using SSTS reported more rapid onset of analgesia and patient and nurse ease of care and satisfaction scores were higher than IV PCA MS. Adverse events were similar between the 2 groups; however, SSTS had fewer patients experiencing oxygen desaturations below 95% compared to IV PCA MS (P = 0.028).
  
  
  CONCLUSIONS
  Sufentanil sublingual tablet system is a promising new analgesic technology that may address some of the concerns with IV PCA.
authors.affiliation: Institution: Helen Keller Hospital, Sheffield, Alabama, U.S.A.
authors.forename: Timothy I
authors.initials: TI
authors.lastname: Melson
authors.forename: David L
authors.initials: DL
authors.lastname: Boyer
authors.forename: Harold S
authors.initials: HS
authors.lastname: Minkowitz
authors.forename: Alparslan
authors.initials: A
authors.lastname: Turan
authors.forename: Yu-Kun
authors.initials: YK
authors.lastname: Chiang
authors.forename: Mark A
authors.initials: MA
authors.lastname: Evashenk
authors.forename: Pamela P
authors.initials: PP
authors.lastname: Palmer
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016058:Analgesia, Patient-Controlled / Q000379:methods; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D017409:Sufentanil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013607:Tablets / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D004338:Drug Combinations; D013607:Tablets; D009020:Morphine; D017409:Sufentanil
keywords: adverse events; onset of analgesia; opioid; oxygen desaturation; patient-controlled analgesia; postoperative pain; sublingual; sublingual tablet system; sufentanil