2,861
Views
0
CrossRef citations to date
0
Altmetric
Research Article

Pooled Phase III Safety Analysis of Sufentanil Sublingual Tablets for Short-Term Treatment of Moderate-to-Severe Acute Pain

, , , , , & show all
Pages 259-271 | Received 20 Nov 2018, Accepted 14 Dec 2018, Published online: 07 Jan 2019

References

  • Sommer M , De RijkeJM , Van KleefMet al. The prevalence of postoperative pain in a sample of 1490 surgical inpatients . Eur. J. Anaesthesiol.25 ( 4 ), 267 – 274 ( 2008 ).
  • Gerbershagen HJ , AduckathilS , van WijckAJ , PeelenLM , KalkmanCJ , MeissnerW . Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures . Anesthesiology118 ( 4 ), 934 – 944 ( 2013 ).
  • McCaig LF , StussmanBJ . National Hospital Ambulatory Medical Care Survey: 1996 emergency department summary . National Center for Health Statistics ( 1997 ). www.cdc.gov/nchs/data/ad/ad293.pdf .
  • Centers for Disease Control (CDC) . Emergency department visits ( 2015 ). www.cdc.gov/nchs/fastats/emergency-department.htm .
  • Pitts S , NiskaRW , XuJ , BurtC . National hospital ambulatory medical care survey: 2006 emergency department summary . National Center for Health Statistics ( 2008 ). www.cdc.gov/nchs/data/nhsr/nhsr007.pdf .
  • Hutchison RW , ChonEH , TuckerWFet al. A comparison of a fentanyl, morphine, and hydromorphone patient-controlled intravenous delivery for acute postoperative analgesia: a multicenter study of opioid-induced adverse reactions . Hosp. Pharm.41 ( 7 ), 659 – 663 ( 2006 ).
  • Smith H . The metabolism of opioid agents and the clinical impact of their active metabolites . Clin. J. Pain.27 ( 9 ), 824 – 838 ( 2011 ).
  • Scott JC , CookeJE , StanskiDR . Electroencephalographic quantitation of opioid effect: comparative pharmacodynamics of fentanyl and sufentanil . Anesthesiology74 ( 1 ), 34 – 42 ( 1991 ).
  • Lehmann KA , GerhardA , Horrichs-HaermeyerG , GrondS , ZechD . Postoperative patient-controlled analgesia with sufentanil: analgesic efficacy and minimum effective concentrations . Acta Anaesthesiol. Scand.35 , 221 – 226 ( 1991 ).
  • Gardner-Nix J . Oral transmucosal fentanyl and sufentanil for incident pain . J. Pain Sympt. Manag.22 ( 2 ), 627 – 630 ( 2001 ).
  • Clark N , MeulemanT , LiuW , ZwanikkenP , PaceN , StanleyT . Comparison of sufentanil-N2O and fentanyl-N2O in patients without cardiac disease undergoing general surgery . Anesthesiology66 ( 2 ), 130 – 135 ( 1987 ).
  • Ved SA , DuboisM , CarronH , LeaD . Sufentanil and alfentanil pattern of consumption during patient-controlled analgesia: a comparison with morphine . Clin. J. Pain.5 ( Suppl. 1 ), S63 – S70 ( 1989 ).
  • Bailey PL , StreisandJB , EastKAet al. Differences in magnitude and duration of opioid-induced respiratory depression and analgesia with fentanyl and sufentanil . Anesth. Analg.70 ( 1 ), 8 – 15 ( 1990 ).
  • Conti G , ArcangeliA , AntonelliMet al. Sedation with sufentanil in patients receiving pressure support ventilation has no effects on respiration: a pilot study . Can. J. Anesth.51 ( 5 ), 494 – 499 ( 2004 ).
  • Golembiewski J , DastaJ , PalmerPP . Evolution of patient-controlled analgesia: from intravenous to sublingual treatment . Hosp. Pharm.51 ( 3 ), 214 – 229 ( 2016 ).
  • Jove M , GriffinDW , MinkowitzHS , Ben-DavidB , EvashenkMA , PalmerPP . Sufentanil sublingual tablet system for the management of postoperative pain after knee or hip arthroplasty: a randomized, placebo-controlled study . Anesthesiology123 ( 2 ), 434 – 443 ( 2015 ).
  • Ringold FG , MinkowitzHS , GanTJet al. Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study . Regional Anesth. Pain Med.40 ( 1 ), 22 – 30 ( 2015 ).
  • Melson TI , BoyerDL , MinkowitzHSet al. Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial . Pain Pract.14 ( 8 ), 679 – 688 ( 2014 ).
  • Minkowitz HS , LeimanD , MelsonT , SinglaN , DiDonatoKP , PalmerPP . Sufentanil sublingual tablet 30 mcg for the management of pain following abdominal surgery: a randomized, placebo-controlled, phase-3 study . Pain Pract.17 ( 7 ), 848 – 858 ( 2017 ).
  • Hutchins JL , LeimanD , MinkowitzHS , JoveM , DiDonatoKP , PalmerPP . An open-label study of sufentanil sublingual tablet 30mcg in patients with postoperative pain . Pain Med.19 ( 10 ), 2058 – 2068 ( 2018 ).
  • Miner JR , RafiqueZ , MinkowitzHS , DiDonatoKP , PalmerPP . Sufentanil sublingual tablet 30 mcg for moderate-to-severe acute pain in the emergency department . Am. J. Emerg. Med.36 ( 6 ), 954 – 961 ( 2018 ).
  • Fisher DM , ChangP , WadaDR , DahanA , PalmerPP . Pharmacokinetic properties of a sufentanil sublingual tablet intended to treat acute pain . Anesthesiology128 ( 5 ), 943 – 952 ( 2018 ).
  • Minkowitz HS , SinglaNK , EvashenkMAet al. Pharmacokinetics of sublingual sufentanil tablets and efficacy and safety in the management of postoperative pain . Regional Anesth. Pain Med.38 ( 2 ), 131 – 139 ( 2013 ).
  • Boonstra AM , StewartRE , KökeAJet al. Cut-off points for mild, moderate, and severe pain on the numeric rating scale for pain in patients with chronic musculoskeletal pain: variability and influence of sex and catastrophizing . Front. Psychol.7 ( 1466 ), 1 – 9 , [ eCollection 2016 ] ( 2016 ).
  • Krebs EE , CareyTS , WeinbergerM . Accuracy of the pain numeric rating scale as a screening test in primary care . J. Gen. Intern. Med.22 , 1453 – 1458 ( 2007 ).
  • Willsie SK , EvashenkMA , HamelLG , HwangSS , ChiangYK , PalmerPP . Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers . Clin. Ther.37 , 145 – 155 ( 2015 ).
  • Lötsch J , SkarkeC , SchmidtH , GroschS , GeisslingerG . The transfer half-life of morphine-6-glucuronide from plasma to effect site assessed by pupil size measurements in healthy volunteers . Anesthesiology95 , 1329 – 1338 ( 2001 ).
  • Zacny JP , LichtorJL , FlemmingD , CoalsonDW , ThompsonWK . A dose-response analysis of the subjective, psychomotor and physiological effects of intravenous morphine in healthy volunteers . J. Pharmacol. Exper. Ther.268 ( 1 ), 1 – 9 ( 1994 ).
  • Kerr B , HillH , CodaBet al. Concentration-related effects of morphine on cognition and motor control in human subjects . Neuropsychopharmacology5 ( 3 ), 157 – 166 ( 1991 ).
  • Kamboj SK , TookmanA , JonesL , CurranHV . The effects of immediate-release morphine on cognitive functioning in patients receiving chronic opioid therapy in palliative care . Pain117 ( 3 ), 388 – 395 ( 2005 ).
  • Alten R , KrügerK , RelleckeJet al. Examining patient preferences in the treatment of rheumatoid arthritis using a discrete-choice approach . Patient Prefer. Adherence10 , 2217 – 2228 ( 2016 ).
  • Eek D , KroheM , MazarIet al. Patient-reported preferences for oral versus intravenous administration for the treatment of cancer: a review of the literature . Patient Prefer. Adherence.10 , 1609 – 1621 ( 2016 ).
  • daCosta DiBonaventura M , WagnerJS , GirmanCJet al. Multinational Internet-based survey of patient preference for newer oral or injectable Type II diabetes medication . Patient Prefer. Adherence.4 , 397 – 406 ( 2010 ).
  • Smith H . A comprehensive review of rapid-onset opioids for breakthrough pain . CNS Drugs26 ( 6 ), 509 – 535 ( 2012 ).
  • Shafer SL , FloodPD . The pharmacology of opioids . In : Geriatric Anesthesiology (2nd Edition) . SilversteinJH , RookeA , RevesJG , McLeskeyCH ( Eds ). Springer Science & Business Media , NY, USA , 209 – 228 ( 2007 ).
  • Singla NK , MuseDD , EvashenkMA , PalmerPP . A dose-finding study of sufentanil sublingual microtablets for the management of postoperative bunionectomy pain . J. Trauma Acute Care Surg.77 ( 3 Suppl. 2 ), S198 – S203 ( 2014 ).
  • Cepeda MS , AfricanoJM , PoloR , AlcalaR , CarrDB . What decline in pain intensity is meaningful to patients with acute pain?Pain105 ( 1–2 ), 151 – 157 ( 2003 ).